Non-randomized Controlled Clinical Trial Research Articles

Diaphragm ultrasonography as a monitor in assessing antagonistic effect of sugammadex on rocuronium in patients with Child-Pugh grades A and B.

Although diaphragm ultrasound can be used for detecting residual neuromuscular blockade post-surgery, there exists notable dearth in contemporary research exploring the correlation between preoperative Child-Pugh classification and the effectiveness of sugammadex in reversing rocuronium-induced blockade as evaluated by diaphragmatic ultrasonography. This was a prospective, double-blind, non-randomized controlled clinical trial conducted on patients scheduled for laparoscopic liver resection surgery. The participants were categorized into two groups, A and B, based on their preoperative Child-Pugh classification. Prior to anesthesia induction, baseline diaphragm thickness was evaluated using ultrasonography. Throughout the surgical procedure, a deep neuromuscular blockade was maintained with rocuronium. Post-surgery, sugammadex (2 mg/kg) was intravenously administered to patients in both groups upon reaching a train-of-four ratio of 0.2. Diaphragm thickness was assessed at 0, 10, and 30 min, as well as 2 h after extubation, to analyze thickening fractioning (TF) and thickness recovery fractioning (TRF). No significant differences in TF or TRF were observed between the two groups at 0, 10, and 30 min, as well as 2 h after extubation. Furthermore, there were no significant variances in hemodynamic stability following sugammadex administration. However, patients in the Child-Pugh B group experienced a significantly prolonged time from sugammadex administration to tracheal extubation (19 ± 8.0 min vs. 11 ± 6.1 min) and an extended post-anesthesia care unit stay (123 ± 28.3 min vs. 103 ± 26.0 min) compared to those in the Child-Pugh A group. The preoperative Child-Pugh grades may not exhibit a significant association with the reversal effect of sugammadex on rocuronium, as evaluated through diaphragmatic ultrasonography. Registered in the ClinicalTrials.gov (NCT05028088) on July 18, 2021.

Effects of Electronic Nicotine Delivery Systems Substitution on Body Weight Status: Protocol for a Systematic Review and Meta-Analysis.

Weight gain following smoking cessation is a well-documented concern, often attributed to the absence of nicotine's metabolic influence. The adoption of Electronic Nicotine Delivery Systems (ENDS) has been used to achieve smoking cessation, with claims of aiding weight control. However, existing reviews present conflicting conclusions on ENDS' impact on weight status, necessitating a rigorous evaluation. We aim to conduct a systematic review with meta-analysis to assess the actual impact of ENDS on weight status in individuals who have ceased or reduced conventional smoking. The primary goal is to provide clinicians with evidence-based insights into the potential effects of ENDS use as a smoking substitute on weight control. Adhering to PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines, our systematic review will analyze randomized and nonrandomized controlled trials, clinical trials (quasi-experimental), and prospective or retrospective cohort studies on the weight status effects of ENDS among individuals who have either quit or reduced smoking. Searches will include PubMed, Scopus, and Cochrane Library, covering the period from 2010 to January 2024. A gray literature search and supplementary searches will be performed. Data will be extracted independently by 2 reviewers and quality assessments will be conducted concurrently. Quality assessments will use Joanna Briggs Institute tools, 2020 version, along with bias assessments for internal validity and reporting bias based on the Catalogue of Bias. The included studies will be examined for any internal data reporting discrepancies by using Puljak's checklist. Meta-analysis and subgroup analyses (ie, general ENDS usage, ENDS use coupled with a reduction in smoking exceeding 50%, and exclusive ENDS use for achieving smoking cessation) are planned. Certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. The protocol has been registered in PROSPERO (CRD42023494974) and the entire systematic review is expected to be completed by April 2024. The main goal of this review is to retrieve all current human research studies investigating the influence of ENDS on weight management among individuals who have quit or reduced smoking. Furthermore, the review will assess the quality of these studies and examine potential biases to identify the most dependable evidence available. Dissemination strategies will include traditional journal publications, social media announcements, and a white paper. The latter, available for download and distributed at conferences, aims to reach a broad audience, including clinicians and ENDS users. The review will address the importance of informing health care professionals and patients about the current and robust evidence regarding the effects of transitioning to ENDS for smoking cessation on weight status. PROSPERO CRD42023494974; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=494974. PRR1-10.2196/56324.

Effect of low-intensity laser therapy on levels of biomarkers during orthodontic tooth movement – A systematic review

This systematic review aimed to explore the association between low-intensity laser therapy (LILT) and various biomarkers, elucidating the potential of this therapeutic modality to expedite orthodontic tooth movement (OTM). A systematic literature search was conducted using electronic databases including PubMed, Central of the Cochrane Library, and Google Scholar databases. Randomized controlled trials (RCTs) and non-randomized controlled clinical trials (nRCTs) using LILT as an adjunct to the standard orthodontic procedures in human and animal subjects as participants were included in the study. The quality of the human and animal studies was assessed using the Revised Cochrane risk of bias tool and Systematic Review Centre for Laboratory Animal Experimentation’s (SYRCLE’s) risk of bias tool respectively. Animal studies revealed increased receptor activator of nuclear factor-kappa B (RANK)/RANK ligand (RANKL), matrix metalloproteinase-9 (MMP-9), and collagen type I expression. Human studies showed elevated interleukin-1-beta (IL-1β), interleukin-16 (IL-16) and RANKL levels, suggesting LILT influences biomarkers associated with bone resorption and connective tissue rearrangement. A high risk of bias was observed in all animal studies and 5 out of 6 human studies. The systematic review concluded that LILT emerges as a promising technique for enhancing orthodontic tooth movement, influencing key biomarkers linked to osteoclastic activity and collagen synthesis. However, the high risk of bias in animal and human studies emphasizes the need for further research to validate findings and optimize laser parameters for clinical benefits.

Effectiveness of reframing as behaviour management technique in paediatric dentistry: A scoping review

Background: For children with fear and anxiety, dental appointments are considered as stressful situations. The dental literature has mentioned various behaviour management techniques used to reduce the dental fear and anxiety. Reframing is one such technique which is used for behaviour management with wide applications in health sciences. Hence, exploring this technique in the dental literature is of prime importance.Objectives: This scoping review aims to identify the evidence on the effectiveness of reframing as behaviour management technique in children undergoing dental treatment in the available literature.Method: The Joanna Briggs Institute methodology for scoping reviews is followed in this study and relevant published data from case reports, randomized and nonrandomized controlled clinical trials and literature reviews published without restricting time line till August 2023 from online databases of PubMed, Scopus, ProQuest were assessed by two reviewers for their suitability with our aim of study. The data were synthesized using content analysis.Results: Through literature search, 108 articles were found based on search strategy. After screening the titles, keywords and abstract and removing the duplicates only 10 articles were included for full text review. In the end only 5 articles were included for scoping review for their content analysis.Conclusions: The searched literature has revealed that reframing had changed the behaviour of the child towards dental outcomes but the literature is sparse regarding behaviour management technique for children to alleviate fear and anxiety. Also, there were no clinical trials done to know the efficacy of this technique and means to measure the outcome.

Exercise Intervention and Hospital-Associated Disability

Inpatient exercise interventions may prevent, at least partly, hospital-associated disability (HAD) in older adults, but whether they also confer clinical benefits in the months following discharge is unclear. To examine the association of exercise and health education with HAD incidence in hospitalized older adults receiving acute hospital care at discharge and 3 months later. This single-center open-label, nonrandomized controlled clinical trial included patients aged 75 years or older seen at an acute care for elders unit at a tertiary public hospital in Madrid, Spain, from May 1, 2018, to June 30, 2022. Patients were allocated to an intervention or control group. Both groups received usual care, but the intervention group also performed a supervised multicomponent exercise program (daily strength, balance, and walking exercises along with inspiratory muscle training) during hospitalization and received health education on how to exercise at home and telephone counseling during follow-up. The primary outcome was HAD incidence (determined by the Katz Index of Independence in Activities of Daily Living [hereafter, Katz Index]) at discharge and after 3 months compared with baseline (ie, 2 weeks before admission). Secondary outcomes included HAD incidence determined by the Barthel Index for Activities of Daily Living, ambulatory capacity decline at discharge and follow-up, changes in physical performance at discharge, and incidence of falls, readmissions, and mortality during the follow-up period. The study included 260 patients (134 women [51.5%]; mean [SD] age, 87.4 [4.9] years [range, 75-105 years]; median hospital length of stay, 7 days [IQR, 5-10 days]), of whom 130 received the intervention and 130 were in the control group. Differences in HAD incidence did not reach statistical significance at discharge (odds ratio [OR], 0.62; 95% CI, 0.37-1.05; P = .08) or follow-up (OR, 0.65; 95% CI, 0.36-1.17; P = .15) when using the Katz Index. A lower HAD incidence was observed in the intervention group at discharge (OR, 0.47; 95% CI, 0.27-0.81; P = .01) and at follow-up (OR, 0.36; 95% CI, 0.20-0.66; P = .001) when using the Barthel Index for Activities of Daily Living. The intervention was also associated with a lesser decline in ambulatory capacity (OR, 0.55; 95% CI, 0.32-0.96; P = .03) and improved physical performance at discharge (Cohen d, 0.39; 95% CI, 0.12-0.65; P = .004). No significant associations were observed for readmissions, falls, or mortality. In this nonrandomized controlled clinical trial, an exercise and health education intervention was not significantly associated with reduced HAD incidence when measured by the Katz Index. However, the benefits found for several secondary outcomes might support the implementation of in-hospital exercise programs for older patients. ClinicalTrials.gov Identifier: NCT03604640.

Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention

BackgroundPatients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making (SDM) models help to understand considerations that influence patients’ decision. Discussion of patient values is essential to SDM, but such communication is often limited in this context and may require new interventions. The OnVaCT intervention, consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists, was previously developed to support SDM. This study aimed to qualitatively explore associations between patient values that are discussed between patients and oncologists during consultations about potential participation in early phase clinical trials before and after implementation of the OnVaCT intervention.MethodsThis study is part of a prospective multicentre nonrandomized controlled clinical trial and had a between-subjects design: pre-intervention patients received usual care, while post-intervention patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients’ initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached.ResultsData saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-intervention and 15 post-intervention). The analysis revealed the values: hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, acceptance of one’s fate, and humanity. Patients in the pre-intervention phase tended to express values briefly and spontaneously. Oncologists acknowledged the importance of patients’ values, but generally only gave ‘contrasting’ examples of why some accept and others refuse to participate in trials. In the post-intervention phase, many oncologists referred to the OnVaCT and/or asked follow-up questions, while patients used longer phrases that combined multiple values, sometimes clearly indicating their weighing.ConclusionsWhile all values were recognized in both study phases, our results have highlighted the different communication patterns around patient values in SDM for potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study therefore provides a first (qualitative) indication that the OnVaCT intervention may support patients and oncologists in discussing their values.Trial registrationNetherlands Trial Registry: NL7335, registered on July 17, 2018.

The Use of Platelet Concentrates in the Reconstruction of the Alveolar Cleft Defect: A Systematic Review and Meta-Analysis.

Evaluate quantitative and qualitative outputs when comparing the incidence of platelet concentrates (PCs) combined with autogenous bone grafts to an autograft control group for the reconstruction of alveolar cleft defects. Systematic review and meta-analysis. Randomized and nonrandomized controlled clinical trials where PCs were used in the reconstruction of alveolar cleft defects. Use of PCs in combination with autogenous bone graft in the experimental group and autogenous bone graft alone in the control group. Average bone formation and bone density were evaluated, mean differences were calculated and pooled by a meta-analysis technique. Additionally, clinical outcomes such as wound dehiscence, closure of the oronasal fistula, pain, swelling, discharges, infections, and bleeding were considered in the qualitative synthesis. After an evaluation of forty-nine articles, nineteen were considered for the review. The qualitative assessment of bone density, bone formation, and clinical outcomes showed no differences between groups in most of the included studies. The meta-analysis showed no statistical differences between PCs groups when compared to the control group in bone density at three months (mean difference 45.67 HU, P = .23) and six months (mean difference 48.57 HU, P = .64). Neither were statistical differences in the percentage of regenerated bone volume at six months (mean difference 6.39%, P = .15) and the volume of newly formed bone at 12 months (mean difference 0.37 mm3, P = .99). There were no significant differences in terms of bone formation, bone density, and clinical outputs between groups.

Effectivity and safety of trifocal intraocular lenses and capsular tension rings implantation for cataract patients with axial high myopia.

To assess effectivity and safety of trifocal intraocular lenses (IOLs) and capsular tension rings in treating cataract patients with axial high myopia. A prospective nonrandomized controlled clinical trial was conducted. Totally 98 eyes (74 patients) who underwent femtosecond laser-assisted cataract surgery (FLACS) with trifocal IOLs were enrolled in the study and followed up for 2y after surgery: 46 eyes (33 patients) with capsular tension ring implantation in the long axial lengths (AL) group (26<AL<29 mm) and 52 eyes (41 patients) in the normal AL group (22<AL<24.5 mm). Postoperative outcomes about effectivity and safety, including the subjective and objective visual quality, and postoperative complications were assessed. Uncorrected distance visual acuity at 5 m and uncorrected intermediate visual acuity at 60 and 80 cm in the long AL group were significantly worse than those in the normal AL group at 3mo postoperatively (P<0.05). The differences in reading speed, spectacle independence and potential visual complaints between the two groups were not statistically significant (P>0.05). The dysfunctional lens index and total modulation transfer function (MTF) average height were similar between the two groups. The postoperative internal coma aberrations in the axial high myopia eyes were significantly higher than that in the normal AL group (P<0.05). The total satisfaction score in the long AL group (91.32±2.76) was slightly higher than that in the normal AL group (90.36±3.47), but there was no difference (P=0.136). A statistically negative correlation was found between corrected distance visual acuity (CDVA) and dysfunctional lens index (r=-0.382, P=0.009), and between CDVA and the total MTF average height (r=-0.374, P=0.01). But there was no significant correlation between CDVA and total satisfaction score (r=0.059, P=0.696). Postoperative complications mainly presented as posterior capsular opacity (PCO), retinal detachment and cystoid macular edema. There was no difference in the incidence of fundus disease (6.5% vs 3.8%, P=0.663) or PCO (17.4% vs 7.7%, P=0.217) between the two groups at two years. The utilization of trifocal IOL and capsular tension ring implantation is beneficial for cataract patients with axial high myopia undergoing FLACS. This approach not only ensures excellent subjective feelings and objective visual quality, but also does not increase the incidence of postoperative complications.

The long-term user experience of an m-Health application

Low user engagement in m-Health applications has been driving the use of retention techniques that aim to ensure a satisfactory long-term user experience. The aim was to understand the experience of hypertensive patients interacting with a mobile health application for 12 months. A qualitative/exploratory study was conducted after 12 months, with the same experimental group of participants as the non-randomized controlled clinical trial conducted in 2019. The mean age of the 16 participants was 57 years (SD=8), of which11 were female. All had low socioeconomic and educational levels. Content analysis showed no engagement with the m-health app over time. The main factors contributing to the lack of engagement were; inability of the user to use the app, lack of support and technical problems. When designing m-Health interventions, it is important to understand users' behavioral characteristics, motivations for treatment, level of involvement in health care, and ability to use technology.

Expanded nursing roles to promote person-centred care for people with cognitive impairment in acute care (ENROLE-acute): study protocol for a controlled clinical trial, process and economic evaluation

BackgroundFor people with cognitive impairment, hospitalisation is challenging and associated with adverse events as well as negative outcomes resulting in a prolonged hospital stay. Person-centred care can improve the quality of care and the experience of people with cognitive impairment during hospitalisation. However, current care processes in German hospitals are rarely person-centred. To enable successful implementation of person-centred care on hospital wards, change agents within the interprofessional team are key. The aim of this study is to test the feasibility and initial effects of a newly developed complex person-centred care intervention for people with cognitive impairment provided by expanded practice nurses in acute care.MethodsWe will conduct an exploratory non-randomised controlled clinical trial with accompanying process and cost evaluation with three intervention and three control wards at one university hospital. The person-centred care intervention consists of 14 components reflecting the activities of expanded practice nurses within the interprofessional team on the intervention wards. The intervention will be implemented over a six-month period and compared with optimised care on the control wards. We will include people aged 65 years and older with existing cognitive impairment and/or at risk of delirium. The estimated sample size is 720 participants. The primary outcome is length of hospital stay. Secondary outcomes include prevalence of delirium, prevalence of agitation, sleep quality, and person-centred care. We will collect patient level data at six time points (t1 admission, t2 day 3, t3 day 7, t4 day 14, t5 discharge, t6 30 days after discharge). For secondary outcomes at staff level, we will collect data before and after the intervention period. The process evaluation will examine degree and quality of implementation, mechanisms of change, and the context of the complex intervention. The economic evaluation will focus on costs from the hospital’s perspective.DiscussionThe ENROLE-acute study will provide insights into the effectiveness and underlying processes of a person-centred care intervention for people with cognitive impairment provided by expanded practice nurses on acute hospitals wards. Results may contribute to intervention refinement and evidence-based decision making.Trial registrationCurrent controlled trials: ISRCTN81391868. Date of registration: 12/06/2023. URL: https://doi.org/10.1186/ISRCTN81391868

Effect of robot for medication management on home care professionals’ use of working time in older people’s home care: a non-randomized controlled clinical trial

BackgroundMedication management has a key role in the daily tasks of home care professionals delivered to older clients in home care. The aim of this study was to examine the effect of using a robot for medication management on home care professionals´ use of working time.MethodsA pragmatic non-randomized controlled clinical trial was conducted. The participants were home care professionals who carried out home care clients’ medication management. Home care clients were allocated into intervention groups (IG) and control groups (CG) (n = 64 and 46, respectively) based on whether or not they received the robot. Data were collected using the Working Time Tracking Form prior to and 1 and 2 months after introducing the intervention. The t-test was used to compare the groups at each three timepoints. Analysis of Covariance was used to examine the groups’ differences for the total time for medications as the number of visits per day as the covariate.ResultsWith robot use, the total amount of home visits decreased by 89.4% and 92.4% after 1 and 2 months of intervention use, respectively, compared to pre-intervention (p < 0.001). The total working time used for medication management considering the number of visits per day decreased from 54.2 min (95% CI 49.6–58.8) to 34.9 min (31.4–38.3), i.e., by slightly over 19 min (p < 0.001) in the IG group. During the follow-up, the total working time used for medication management considering the number of visits per day remained the same in the CG group.ConclusionUsing a robot for medication management had a notable effect on decreasing the use of working time of home care professionals. For health services, decreased use of working time for medication management means that the time saved can be assigned to services that cannot be replaced otherwise. More digital solutions should be developed based on home care clients’ and professionals’ needs to meet the challenge of the growing number of older people in need of home care and ensure their safety.Trial registrationClinicalTrials.gov Identifier: NCT05908604 retrospectively registered (18/06/2023).

The effect of basic carbohydrate counting on HbA1c in type 2 diabetic patients: A non-randomized controlled trial

AimTo evaluate the effect of basic carbohydrate counting (CC) on HbA1c in Type 2 Diabetes (T2D) patients using oral antidiabetic drugs in the primary care. MethodThe study is a non-randomized controlled clinical trial. T2D patients, aged between 18 and 75 years, HbA1c ≥ 6,5 %, using oral antidiabetic medication, were followed for three months in two groups: one intervention (IG) (n = 33), one control group (CG) (n = 45), in two different Primary Care Centers. General diabetes care was applied in both groups; basic CC training was given additionally to the IG. An informative CC booklet was distributed to both groups. Beside sociodemographic questionnaire, CC knowledge scale was applied to all participants; HbA1c, other laboratory, anthropometric measurements were performed at the beginning and at the 3rd month of the study. ResultsAt the third month, HbA1c decreased within the IG from 7.7 % to 7.2 % (p:0.002), from 7.49 % to 7.46 %, in the CG (p:0.851). Comparing groups, the decrease in HbA1c in the IG was higher than in the CG (−0.5, −0.02, p: 0.018). Third month knowledge score was higher the IG’s (<0.001). ConclusionBasic CC training provided to T2DM patients, improves glycemic control by improving HbA1c and increasing CC knowledge.

Pain perception and expectation related to interradicular mini-implants insertion: a systematic review and meta-analysis.

The aim of this systematic review was to compare the expectation and perception of pain reported by patients before and after the installation of interradicular mini-implants. Electronic search was performed in six databases. Inclusion criteria were randomized controlled trials (RCTs) or non-randomized controlled clinical trials (nRCTs); studies using mini-implants in the interradicular region; assessment of pain intensity by visual analogue or numerical scale. The risk of bias assessment was based on the Rob 2 tool and Robins-I. A total of 1566 articles were retrieved, and 21 met the eligibility criteria. Six were classified as high risk, one as critical and the other one as uncertain, according to the Robins-I tool. In articles evaluated by the Rob2 tool, ten were classified as serious risk and three as moderate risk. A meta-analysis was also performed. Weighted means were calculated among the studies using the random-effects model and forest plots were generated. Heterogeneity was assessed through the Q test and I2 statistics. It was observed, with moderate evidence, that on a scale of 0 to 10, the pain expectation (effect size 4.75) is higher than that effectively pain generated by the procedure (effect size 1.94). Pain expectation was greater than that actually generated by the procedure, being almost non-existent 7 days postoperatively. This study may help the clinician to reassure the patient regarding the sensations that could be experienced during and after the installation.

Efficacy Of Vibroacoustic Therapy In Treatment Of Pneumonia In Children With Bronchopulmonary Dysplasia

Background — Advances in neonatal intensive care have resulted in high survival rates for infants born with extremely low birth weight. Accordingly, the treatment and rehabilitation of premature neonates with bronchopulmonary dysplasia (BPD) is indisputably an urgent problem. Objective — To evaluate the efficacy of vibroacoustic therapy in patients with BPD in the complex of therapeutic measures. Material and Methods — The study was a prospective, non-randomized open-label controlled clinical trial conducted in 2018-2020 in Astana, Kazakhstan. It included 69 children with BPD hospitalized with a concomitant diagnosis of pneumonia between the ages of 1 and 2 years. The study subjects were distributed among two groups: Group 1 (the main group, n=37) receiving vibroacoustic therapy with the VibroLung apparatus in combination with the main treatment and Group 2 (the control, n=32) receiving solely the main treatment. Results — The inclusion of the vibroacoustic method of treatment in the combination therapy of pneumonia in children with BPD resulted in early leveling of the following clinical symptoms: a reduction in the duration of the high fever by 1.18 days vs. the control group (p&lt;0.05), relief of respiratory failure 1.4 days earlier vs. the control group (p&lt;0.05) and a decrease in the duration of inpatient treatment by 2.9 days, compared with the control group (p&lt;0.05). All of these implied the efficacy of this treatment method. Conclusion — Our results demonstrated that vibroacoustic therapy was a relevant addition to the treatment of pneumonia in children with BPD.

Lower limb muscle strength and balance in older adults with a distal radius fracture: a systematic review

BackgroundDistal radius fractures are common fractures in older adults and associated with increased risk of future functional decline and hip fracture. Whether lower limb muscle strength and balance are impaired in this patient population is uncertain. To help inform rehabilitation requirements, this systematic review aimed to compare lower limb muscle strength and balance between older adults with a distal radius fracture with matched controls, and to synthesise lower limb muscle strength and balance outcomes in older adults with a distal radius fracture.MethodsWe searched Embase, MEDLINE, and CINAHL (1990 to 25 May 2022) for randomised and non-randomised controlled clinical trials and observational studies that measured lower limb muscle strength and/or balance using instrumented measurements or validated tests, in adults aged ≥ 50 years enrolled within one year after distal radius fracture. We appraised included observational studies using a modified Newcastle-Ottawa Scale and included randomised controlled trials using the Cochrane risk-of-bias tool. Due to the clinical and methodological heterogeneity in included studies, we synthesised results narratively in tables and text.ResultsNineteen studies (10 case-control studies, five case series, and four randomised controlled trials) of variable methodological quality and including 1835 participants (96% women, mean age 55–73 years, median sample size 82) were included. Twelve included studies (63%) assessed strength using 10 different methods with knee extension strength most commonly assessed (6/12 (50%) studies). Five included case-control studies (50%) assessed lower limb strength. Cases demonstrated impaired strength during functional tests (two studies), but knee extension strength assessment findings were conflicting (three studies). Eighteen included studies (95%) assessed balance using 14 different methods. Single leg balance was most commonly assessed (6/18 (33%) studies). All case-control studies assessed balance with inconsistent findings.ConclusionCompared to controls, there is some evidence that older adults with a distal radius fracture have impaired lower limb muscle strength and balance. A cautious interpretation is required due to inconsistent findings across studies and/or outcome measures. Heterogeneity in control participants’ characteristics, study design, study quality, and assessment methods limited synthesis of results. Robust case-control and/or prospective observational studies are needed.RegistrationInternational prospective register of systematic reviews (date of registration: 02 July 2020, registration identifier: CRD42020196274).

Evaluation of patients treated by telemedicine in the beginning of the COVID-19 pandemic in São Paulo, Brazil: A non-randomized clinical trial preliminary study

We performed a pilot open-label, non-randomized controlled clinical trial in a clinic in São Paulo, Brazil in the beginning of the COVID-19 pandemic.“This medical pilot project was carried out during the pandemic of a new and unknown agent. It was necessary to find a new and safe therapeutic approach for pathogens with high potential for severity and contamination. The repositioning of safe and accessible pre-existing and approved medications and the telemedicine approach improved treated covid patients’ symptoms and reduced the risk of disease transmission. The emergency application of a new medical technology was the major limitation of the study. This innovative care model is a low-cost safe strategy, and we understand that applicability can be expanded to other regions in emergency situations.”The 187 patients of the study (mean age of 37.6 ± 15,6 years) were divided into four groups: (1) asymptomatic, (2) mild symptoms, (3) moderate symptoms and (4) severe symptoms and were followed up for five days. A drug intervention was performed in group 3 and the patients of Group 4 were oriented to seek hospital care. Of all the patients, 23.0% were asymptomatic, 29.4% reported mild symptoms, 43.9% moderate symptoms and 3.7% severe symptoms. Three patients were hospitalized and discharged after recovery. Our results indicate that the use of telemedicine with diagnosis and drug treatment is a safe and effective strategy to reduce overload of health services and the exposure of healthcare providers and the population. The patients that initiated the treatment in the early stages of the disease presented satisfactory clinical response, reducing the need of face-to-face consultations and hospitalizations. The patients who followed the protocol treatment for COVID-19 with hydroxychloroquine and azithromycin for five days presented statistically significant improvement of clinical symptoms when compared to moderate patients who opted for not following the protocol (p < 0.05) and to all no treatment patients (p < 0.001).

Effect of Montelukast on Treatment of Coronavirus Pneumonia (COVID-19): A Systematic Review

Background: The coronavirus disease 2019 (COVID‐19) exhibits the most important global public health emergency. Montelukast (MTL), a prototype cysteinyl leukotriene receptor antagonist, is commonly considered in the therapy of exercise- and aspirin-induced asthma. The purpose of this study was to present a systematic review of the literature on the effectiveness of MTL against severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and exuberant immune activation in COVID‐19 disease. Methods: PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials were searched from the database on August 15, 2021and updated on November 19, 2022. Two reviewers independently screened articles, appraised methodological quality, and extracted the data. Results: A total of 118 related reports were recognized after eliminating duplicates. Of these, 30 references were screened based on titles and abstracts. After removing unrelated studies, 20 studies were included in the full-text review and evaluated for appropriateness. Finally, eight studies fitting the inclusion criteria for data extraction were selected. One of them was a prospective, randomized, controlled, and single-blinded study, three were open-label randomized or non-randomized controlled clinical trials, two were retrospective studies, and two were case series or comparative studies. A total of 1083 patients infected with COVID-19 infection (999 adults and 84 children) were examined on the effectiveness of MTL on symptom severity as well as hospitalization length. The results of the mentioned studies showed a low risk of clinical deterioration in the MTL group. In addition, the length of hospital stay was low in the treatment group compared to the standard management. Conclusion: MTL as a potential adjuvant therapy in COVID-19 may improve lung injury, inflammation, and symptoms. Moreover, the use of MTL could decrease the severity and mortality of COVID-19. Additional well-designed randomized controlled trials are necessary to approve the role of MTL in SARS-CoV-2 prevention or COVID-19 symptoms improvement.

Intratympanic Botulinum Toxin Injection as a New Therapeutic Modality for Middle Ear Myoclonic Tinnitus.

Middle ear myoclonic tinnitus (MEMT) is a disease caused by myoclonus or abnormal contractive movement of middle ear muscles (MEMs). This translational study was conducted to propose intratympanic botulinum toxin (IT-BTX) injection as a new therapeutic modality to treat MEMT. Animal experiment and nonrandomized controlled clinical trial. Laboratory and medical center of an academic tertiary medical institution. For the animal study, male Sprague-Dawley rats were divided into 4 subgroups according to the sacrificing day after IT-BTX injection. After initial hearing tests, randomly assigned experimental ears were intratympanically injected with 1 unit/100 μL of BTX-A, whereas control ears were injected with normal saline. Changes in the hearing thresholds, morphometry of the cochleae, electron microscopy study, and immunofluorescence analysis of MEMs were evaluated. For the human study, 10 intractable MEMT patients were enrolled. The hearing thresholds and the degree of tinnitus distress were observed for changes after IT-BTX injection. All patients were followed up for 3 months. As for the animal study, there were no significant changes in hearing thresholds and cochlear morphologies in all 4 subgroups of the rats. Significant MEM degenerations and immuno-detection of cleaved synaptosome-associated protein of 25 kDa (cSNAP-25) indicated the efficacy of IT-BTX. MEMT patients enrolled for the pilot clinical trial showed statistically significant improvement in tinnitus after IT-BTX injection. No major complications were noted. The new therapeutic modality of IT-BTX injection for the treatment of MEMT seems highly promising with an excellent result.

Does high-intensity laser therapy speed return to primary function in horses with suspensory ligament desmopathy?

PICO question In horses with a suspensory ligament branch injury, does high-intensity laser therapy (energy output greater than 500 mW) combined with conservative management, compared to conservative management alone, result in a faster return to primary function? Clinical bottom line Category research Treatment. Number and type of study deisgns reviewed The number and type of study designs that were critically appraised were two peer-reviewed studies: a non-randomised controlled clinical trial and a randomised controlled experimental study. Strength of evidence Weak. Outcomes reported The outcomes reported are summarised as follows: the two appraised studies report positive effects of high-intensity laser therapy (HILT) on equine tendon and ligament injuries as measured by pain to palpation, lameness, swelling and ultrasonographic and magnetic resonance imaging (MRI) evaluation of HILT-treated lesions. Conclusion In view of the strength of evidence and the outcomes from the studies the following conclusion is made: the two appraised studies provide only weak evidence to show that horses treated with high-intensity laser therapy (HILT) and conservative management return to primary function sooner than horses treated with conservative management alone. Issues of design, methodology, statistical analysis and reporting reduce the reliability and external validity of these studies. How to apply this evidence in practice The application of evidence into practice should take into account multiple factors, not limited to: individual clinical expertise, patient’s circumstances and owners’ values, country, location or clinic where you work, the individual case in front of you, the availability of therapies and resources. Knowledge Summaries are a resource to help reinforce or inform decision making. They do not override the responsibility or judgement of the practitioner to do what is best for the animal in their care.

Bibliometric assessment in implant-retained overdenture articles: Mapping citation and journal impact factor trends

Statement of problemImplant-retained overdentures are a recognized treatment option. However, a comprehensive assessment of all articles on implant-retained overdentures to identify publication standards such as mean citation and the Journal Citation Reports (JCR) impact factor is lacking. PurposeThe purpose of this bibliometric assessment was to evaluate the association of mean citation and JCR impact factor with bibliometric parameters in articles on implant-retained overdentures. Material and methodsArticles reporting randomized controlled clinical trials (RCTs) and nonrandomized controlled clinical trials (N-RCTs); case reports and series; retrospective studies; and in silico, in vitro, or systematic reviews in 6 databases were included. Data were extracted, and 2 multiple Poisson regressions analyses were applied (α=.05). The dependent variables were mean citation and JCR impact factor, which were evaluated to identify their association with bibliometric parameters by using prevalence ratio (PR) values. ResultsA total of 1369 articles published from 1986 to 2021 were included. The data revealed a high mean citation and high JCR impact factor for RCT, N-RCT, retrospective, and in vitro studies (P<.05). In silico studies presented a high mean citation (P<.001). Senior researchers with a high h-index were more likely to have a high mean citation and publications with a high JCR impact factor (P<.001). Also, senior authors associated with an international network were more likely to have a high mean citation (P=.001). High-income countries had more studies with a high mean citation and JCR impact factor (P<.05). Higher JCR impact factors were associated with articles evaluating only the maxilla or mandible (P<.05). The topics “implant setting” and “macrodesign” were associated with a high mean citation (P<.05). ConclusionsThe publication trends suggest a high mean citation and a high JCR impact factor for clinical designs (RCT, N-RCT, retrospective) and in vitro studies. The same pattern was also displayed for researchers with a high h-index and located in high-income countries.