Non-randomized Controlled Study Research Articles

The links between adipose tissue DNA methylation, obesity, and insulin resistance: A protocol for systematic review.

Obesity is a metabolic condition brought on by the interplay of hereditary and environmental factors, making it one of the most common diseases in the world. Insulin resistance (IR) and obesity have a close connection and can both be advantageous. One of the main methods of epigenetic regulation is DNA methylation modification. Studies have demonstrated over the past few years that DNA methylation is crucial to the emergence of obesity and DNA methylation can lead to IR. Adipose tissue participates in the physiopathological processes of obesity and IR and functions as an endocrine organ controlling the body's balanced metabolism, thus, adipose tissue-associated gene DNA methylation affects the development of obesity and IR by influencing the function of adipose tissue. Hence, an explanation of current research on DNA methylation, IR, and obesity, following the most recent developments, exploring changes in DNA methylation in different types of adipose tissue in insulin-resistant patients and obese patients may enable the identification of novel targets in clinical obesity prevention and treatment. The following electronic bibliographic databases will be searched from inception for peer-reviewed original research published: MEDLINE (through PubMed), Scopus, and EMBASE. Cochrane Library, Cochrane Clinical Trials Registry, the National Institutes for Health Clinical Trials Registry, and the WHO International Clinical Trials Registry Platform from inception to December 31, 2021 will be conducted. Systematic reviews will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. The development of search strategies will make use of medical issue phrases and keywords associated with DNA methylation, Adipose tissue DNA methylation, obesity, and IR. Identified citations will be independently reviewed by two authors to determine eligibility at the title and abstract level, and then at the full text and data extraction phases. Disagreements and conflicts will be resolved through discussion with a third author. Two authors will extract the necessary data from the included studies independently, and The Cochrane Risk of Bias Assessment Tool will be used to assess the bias of randomized controlled studies, and the Newcastle-Ottawa scale for nonrandomized controlled studies. If the interventions and outcomes evaluated are sufficiently homogeneous, results from subgroups of studies will be pooled together in a meta-analysis.

Effect of Experiential Communication Skills Education on Graduate Medical Education Trainees' Communication Behaviors: A Systematic Review.

A better understanding of how communication skills education impacts trainees' communication skills is important for continual improvement in graduate medical education (GME). Guided by the Kirkpatrick Model, this review focused on studies that measured communication skills in either simulated or clinical settings. The aim of this systematic review was to examine the effect of experiential communication skills education on GME trainees' communication behaviors. Five databases were searched for studies published between 2001 and 2021 using terms representing the concepts of medical trainees, communication, training, and skills and/or behaviors. Included studies had an intervention design, focused only on GME trainees as learners, used experiential methods, and had an outcome measure of communication skills behavior that was assessed by a simulated or standardized patient (SP), patient, family member, or outside observer. Studies were examined for differences in outcomes based on study design; simulated versus clinical evaluation setting; outside observer versus SP, patient, or family member evaluator; and length of training. Seventy-seven studies were ultimately included. Overall, 54 (70%) studies reported some positive findings (i.e., change in behavior). There were 44 (57%) single-group pre-post studies, 13 (17%) nonrandomized control studies, and 20 (26%) randomized control studies. Positive findings were frequent in single-group designs (80%) and were likely in nonrandomized (62%) and randomized (55%) control trials. Positive findings were likely in studies evaluating communication behavior in simulated (67%) and clinical (78%) settings as well as in studies with outside observer (63%) and SP, patient, and family member (64%) evaluators. This review demonstrates strong support that experiential communication skills education can impact GME trainees' communication behaviors. Marked heterogeneity in communication trainings and evaluation measures, even among subgroups, did not allow for meta-analysis or comparative efficacy evaluation of different studies. Future studies would benefit from homogeneity in curricular and evaluation measures.

Intermittent Use of Anti-Hormonal Agents for the Endocrine Therapy of Sex-Hormone-Dependent Breast and Prostate Cancer: A Protocol for a Systematic Review.

Therapies with the continuous administration of anti-hormonal agents in sex-hormone-dependent malignancies such as prostate and breast carcinomas often lead to the development of resistant tumor cells. A systematic evaluation of the use and effects of the intermittent application of endocrine therapy could provide information on the state of knowledge in this research area. PubMed, Cochrane Library, Embase, and Web of Science will be systematically searched using pretested search strategies. Randomized and non-randomized controlled trials, pragmatic trials, case-control, and comparative cohort studies will be eligible. Primary outcomes will be progression-free survival, disease-free survival, and overall survival. The literature retrieved will be selected based on predefined inclusion and exclusion criteria. Relevant data will be extracted from included references into a pre-designed table. The risk of bias will be assessed, and the report of the results will follow PRISMA recommendations and include any deviations from this protocol. The increasing prevalence of breast and prostate cancer and limitations of current therapeutic approaches require a closer look at alternatives. Additionally, to explore new therapeutic agents, modalities of administration should be rigorously reviewed to determine the best regimens for patients. This proposed systematic review aims to summarize and evaluate the current knowledge regarding intermittent endocrine cancer therapy to provide a basis for further research.

The effect of emergency department pharmacists on drug overuse and drug underuse in patients with an ADE-related hospitalisation: a controlled intervention study

BackgroundDrug overuse or drug underuse are the most common causes of adverse drug events and can lead to hospital admissions. Using clinical pharmacists in the emergency department may improve patient safety as they are specialised in recognising of adverse drug events and tackling drug overuse and drug underuse. This study tested the effect of an emergency department pharmacist on the number of medication changes for drug overuse and drug underuse taking place in patients with an adverse drug event-related hospitalisation following an emergency department visit.MethodsA multicenter prospective non-randomized controlled intervention study was conducted in a university hospital and a general teaching hospital. Trained emergency department pharmacists included patients in the intervention group with a hospital admission related to an adverse drug event. The interdisciplinary intervention consisted of a pharmacist-led medication review, patient counselling regarding medication, and information transmission to general practitioners and community pharmacies after discharge. The control patients were also admitted after an emergency department visit and received the usual care. The primary outcome was the number of medication changes for drug overuse and drug underuse that took place during hospital admission and persisted 6 months thereafter. Poisson regression analysis was used to estimate the difference in these medication changes between the intervention group and the control group.ResultsA total of 216 patients were included (intervention group 104, control group 112). In the intervention group, 156 medication changes for drug overuse and drug underuse persisted 6 months after admission compared to 59 in the control group (adjusted rate ratio 1.22 [95%CI 1.01-1.49] p = 0.039).ConclusionEmergency department pharmacists do contribute to reduction of drug overuse and drug underuse of medication in patients with a hospitalisation related to adverse drug events after an emergency department visit.

A Systematic Review of Omega-3 Fatty Acid Consumption and Cognitive Outcomes in Neurodevelopment.

This systematic review addresses the effects of n-3 long-chain polyunsaturated fatty acids consumption on human neurodevelopment. It evaluates articles published between 2000 and 2022 investigating the cognitive outcomes during the period of neurodevelopment: from fetal development to adolescence. For the purpose of this review the terms LC PUFA and omega-3 fatty acid will be used interchangeably. Data were sourced from several major databases including PubMed (MEDLINE), Web of Science, and ProQuest Central. Randomized controlled trials (RCTs), nonrandomized controlled trials, prospective or retrospective cohort studies, and observational studies investigating the effects of omega-3 fatty acid consumption from dietary supplements, multiple-nutrient supplement, or food questionnaire on neurodevelopment were considered. Study population was separated in three developmental phases: (1) in-utero, (2) lactation/infancy, and (3) childhood/adolescence. Each article was evaluated for several key factors such as study type, type/dosage of PUFAs, number of subjects, length of intervention, participant age range, population characteristics, outcome measure (both primary/cognitive and secondary/other), results, conclusion, and confounding variables/limitations. A total of 88 articles were included in the review, 69 RCTs and 19 longitudinal or observational studies. The results indicate equivocal effect of intervention, with some short-term benefits observed in the areas of visual attention, working memory, executive function, and communication. Omega-3 supplement might have a short-term positive impact on neurodevelopment in all three phases. Supplementation is recommended throughout life, rather than only during the earliest developmental stage.

Ixazomib, Lenalidomide, and Dexamethasone (IRd) Versus Ixazomib, Pegylated Liposomal Adriamycin, and Dexamethasone(IDd) in Elderly Frail Newly Diagnosed Multiple Myeloma with GA Score ≥2: A Prospective Multicenter Study

Introduction Frailty patients with newly diagnosed multiple myeloma (NDMM) have inferior survival and higher rate of treatment discontinuation due to complications, poor tolerance and compliance and lack of effective treatment. The aim of this study was to prospectively investigate the treatment tolerability, clinical outcomes and quality of life of the ixazomib based regimens in frail NDMM patients according to IMWG frailty index. This trail is registered at http://www.chictr.org.cn/index.aspx as chiCTR1900024917. Methods This prospective trail was an investigator initiate, multicenter, non-randomized controlled study which frail NDMM patients received 6-8 four-week induction cycles of ixazomib, lenalidomide and dexamethasone (IRd) and ixazomib, pegylated liposome adriamycin and dexamethasone (IDd), followed by matienance therapy of 4-week with ixazomib and dexamethasone (Id) until progression. Inclusion criteria were aged ≥ 65 years, IMWG GA score ≥ 2 or Mayo geriatric vulnerability scoring system defined as vulnerable. Main exclusion criteria were acute cardiovascular and cerebrovascular events. The primary endpoint was overall response rate (ORR) defined by having at least a partial response (≥PR). The secondary endpoints were progression free survival (PFS), overall survival (OS), adverse events (AE) and health-related quality of life (using the EORTC-QLQ C30). Results From July 2019 to December 2021, a total of 132 patients from 15 hospitals were enrolled of which 12 were excluded because of ineligibility and non-randomized assigned to receive IRd group (n=60) or IDd (n=60) according to doctor's estimated (Figure 1). The median age was 71 years range (65-88). All patients had a GA Index higher than 2 score, in which 27.5% were also defined fragile by Mayo criterion. The ORR was 83%, including 22 (19.6%) patients with a complete response (CR) and 45 (40.2%) with a very good partial response (VGPR). The ORR was 84.2% and 81.8%, CR was 26.3% and 17.2, VGPR was 36.8% and 43.6% of IRd and IAd group, respectively. After a median follow-up time of 22.9m (95% CI 18.9-26.9), the median PFS was 19.5m of all patients, 24.6m and 15.8 of IRd and IDd group, respectively. The median OS of all patients and IRd group was no reach, while 29.2m in IDd group (Figure 1). Four patients died in 60 days post enroll up because of pneumonia caused by bedridden. Twenty-six and thirty-six patients did not process to maintenance therapy in IRd and IAd group, due to PD (14 in IRd and 16 in IDd), AE (6 in IRd and 7 in IDd), incompliance (5 in IRd and 9 in IDd) and early death (1 in IRd and 3 in IDd). Cumulative grade 3 or higher hematological AEs occurred in 10/60 (16.7%) and 13/60 (21.7%), whereas grade ≥3 non-hematological AEs were reported in 25/60 (41.7%) and 46/60 (76.6%) patients. Most common non-hematological grade ≥3 AEs were infections (20.8%) and gastro-intestinal (13.3%). Only 1 patient experiencing PNP grade 3 (0.83%). During induction, patients experienced a statistically and clinically significant improvement in GHS/QoL of both IRd and IAd group (p<0.0001). (Figure 1) Conclusion The results of ORR and safety support the use of IDd or IRd as frontline therapy for fragile elderly MM patients, which also improves QoL. IDd was especially suitable for frail MM patients with renal dysfunction and thrombosis. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Effect of sodium-glucose cotransporter-2 inhibitors on aldosterone and renin levels in diabetes mellitus type 2 patients: a systematic review and meta-analysis

The effect of sodium-glucose cotransporter-2 inhibitors (SGLT2i) on plasma aldosterone concentration (PAC) and plasma renin activity (PRA) levels are still inconclusive. This meta-analysis aimed to demonstrate the changes in PAC and PRA levels after the use of SGLT2i in type 2 diabetes patients. A search for relevant publications was performed using PubMed/Medline, Scopus, Cochrane, and Embase databases from their inception through May 2022. Inclusion criteria were studies that contained data on crude PAC and PRA levels before and after the use of SGLT2i in adult type 2 diabetes patients. Standardized mean difference (SMD) with a 95% confidence interval (95% CI) was calculated. Data was separately analyzed by study design: randomized controlled study (RCT) and non-randomized controlled study (non-RCT). Ten studies involving 380 patients were included with two RCT and eight non-RCT. Serum PAC levels showed no significant change after the use of SGLT2i in both RCT and non-RCT. Significantly higher PRA levels were observed after the use of SGLT2i in both RCT and non-RCT with SMD of 0.40 ng/mL/hr; 95% CI (0.06, 0.74) and SMD of 0.36 ng/mL/hr; 95%CI (0.17, 0.55), respectively. Subgroup analysis found significantly higher PRA levels after the use of SGLT2i (SMD 0.45 ng/mL/hr; 95% CI (0.18, 0.71)) only in subgroups that used for three months or less. The use of SGLT2i in diabetes mellitus type 2 patients can affect PRA levels, especially during short-term use. PRA levels should be interpreted with caution in this population.

A Case-Control Study on the Changes in High-Sensitivity C-Reactive Protein and Tumor Necrosis Factor-Alpha Levels with Surgical Treatment of OSAS.

Obstructive sleep apnea syndrome (OSAS) is a common but underdiagnosed condition with significant health and economic implications for society. Inflammatory mediators are proposed to be associated with the presence and severity of OSAS and contribute to morbidity and mortality. This paper details a prospective non-randomized case control study of a cohort of subjects, who underwent surgical treatment of OSAS and were enrolled to assess the sleep parameters and blood levels of selected inflammatory markers at pre-operative and post-operative time points, also comparing them to the levels in a control group. A total of 25 study subjects and 18 control subjects were enrolled. Median values and interquartile range (IQR) of the apnea-hypopnea index (AHI) in the study group pre-operatively and post-operatively were 34 (18.5-45.5) and 13.3 (7.5-27.3), while in the control group 1.4 (1.0-2.1) per hour. The mean (IQR) hs-CRP levels (mg/L) were 1.782 (0.941-5.594) and 1.980 (0.990-5.445) in the study group, pre-operatively and post-operatively, respectively, while 0.891 (0.767-1.436) in the control group. The mean (IQR) TNF-α levels (pg/mL) were 7.999 (6.137-9.216) and 6.614 (5.534-7.460) pre-and post-operatively, respectively, and were 6.000 (5.026-6.823) in the control group. Results demonstrated that both inflammatory markers, hs-CRP and TNF-α, are higher in subjects with OSAS compared to the controls, and their levels decrease, but are still higher than the controls, after successful surgical treatment. Further analysis including the body mass index and age demonstrated that these changes were significant for TNF-α, but not hs-CRP.

Effects of physical activity on the severity of illness and mortality in COVID-19 patients: A systematic review and meta-analysis.

Purpose: This systematic review and meta-analysis investigated the association between Physical activity (PA) before Coronavirus Disease 2019 (COVID-19) infection and the severity of illness and mortality in COVID-19 patients. Methods: A comprehensive search was undertaken to identify retrospective and nonrandomized controlled trial studies comparing the severity and mortality of COVID-19 infection among COVID-19 patients who had previously reported their participation in PA with those who had not. The databases searched were PubMed, Cochrane Library, Scopus, Science Direct, EMBASE, OPENGREY.EU, and ClinicalTrials.gov. The risk of bias was assessed using the Newcastle-Ottawa Scale. A random-effects model was used for determining pairwise meta-analyses. The protocol was registered with PROSPERO (CRD42021262548). Results: Eighteen studies met the inclusion criteria (5 cross-sectional, 12 cohort, and 1 case-control studies). All 1 618 680 subjects were adults. PA significantly decreased the risk of death in COVID-19 patients (odds ratio [OR] 0.34; 95% confidence interval [CI], 0.19-0.62; p < 0.001) and the risk of severe outcomes (OR 0.60; 95% CI, 0.48-0.76; p < 0.001). Subgroup analysis showed that PA for ≥150min/wk at a moderate intensity or ≥75min/wk at a vigorous intensity reduced the risks of severity and mortality. Vigorous PA reduced mortality risk, whereas moderate to vigorous PA reduced the risks of severity and mortality. Conclusion: PA before infection might reduce severity and mortality in COVID-19 patients, especially PA ≥ 150min/wk of moderate activity or ≥75min/wk of vigorous activity. However, careful interpretations should be considered due to the difference in PA patterns and severity definitions among included studies. This finding implies that engaging in regular PA, even in different patterns, has beneficial effects on the severity and mortality of COVID-19 patients.

Bracing Interventions Can Help Adolescents with Idiopathic Scoliosis with Surgical Indication: A Systematic Review.

There is a common agreement that bracing is appropriate for curves between 20 and 40° for the Cobb angle during growth, but for larger curves, the experts' opinions are not consistent. We designed this systematic review to report the updated evidence about the effectiveness of bracing in scoliosis patients with curves ≥40° and a residual growth period. We included randomized controlled trials, non-randomized controlled trials, prospective and retrospective observational studies, and case series addressing the effect of bracing in patients with idiopathic scoliosis during growth with curves ≥40° for the Cobb angle, published from 2000 onwards. Outcome: The percentage of patients with surgery, curves above 45° or 50°, and a Cobb angle change are all included in the study. Nine papers (563 patients, average worst curve of 44.8°) are included: four are retrospective case series, two are retrospective and two are prospective cohort studies, and one is a prospective controlled study. The overall quality was good, with respect to the type of design. A total of 32% of the patients improved, 26% were stable, and 42% worsened. The rate of improvement ranged from 11% to 78%; the rate of worsening ranged from 4% to 64%. There are some studies suggesting the use of bracing even in the case of severe curves when patients are motivated by trying to avoid surgery. More and better-quality research with coherent outcome criteria is needed.

Intrinsic capacity rather than intervention exposure influences reversal to robustness among prefrail community-dwelling older adults: A non-randomized controlled study of a multidomain exercise and nutrition intervention.

The differential risk profiles associated with prefrailty may be attributable to underlying intrinsic capacity (IC). We examine (i) effect of a multi-domain physical exercise and nutrition intervention on pre-frailty reversal in community-dwelling older adults at 1-year, and (ii) whether IC contributes to pre-frailty reversal. Prefrail participants in this non-randomized study were invited to attend a 4-month exercise and nutritional intervention following a frailty screen in the community. Prefrailty was operationalized as (i) FRAIL score 1-2 or (ii) 0 positive response on FRAIL but with weak grip strength or slow gait speed based on the Asian Working Group for Sarcopenia cut-offs. Participants who fulfilled operational criteria for prefrailty but declined enrolment in the intervention programme served as the control group. All participants completed baseline IC assessment: locomotion (Short Physical Performance Battery, 6-minute walk test), vitality (nutritional status, muscle mass), sensory (self-reported hearing and vision), cognition (self-reported memory, age- and education adjusted cognitive performance), psychological (Geriatric Depression Scale-15, self-reported anxiety/ depression). Reversal of prefrailty was defined as achieving a FRAIL score of 0, with unimpaired grip strength and gait speed at 1-year follow-up. Of 81 participants (70.0 ± 6.6 years, 79.0% female), 52 participants (64.2%) were enrolled in the multi-domain intervention, and 29 participants (35.8%) who declined intervention constituted the control group. There was no difference in age, gender and baseline composite IC between groups. Reversal to robustness at 1-year was similar between intervention and control groups (30.8% vs. 44.8% respectively, p = 0.206). Reduced prevalence of depression was observed among participants in the intervention group at 1-year relative to baseline (7.8% vs. 23.1%, p = 0.022). In multiple logistic regression, intervention had no effect on prefrailty reversal, while higher composite IC exhibited reduced likelihood of remaining prefrail at 1-year (OR = 0.67, 95% CI 0.45-1.00, p = 0.049). Focusing only on the locomotion and vitality domains through a combined exercise and nutritional intervention may not adequately address component domain losses to optimize prefrailty reversal. Future studies should examine whether an IC-guided approach to target identified domain declines may be more effective in preventing frailty progression.

Evidence summary of early rehabilitation of adults with veno-venous extracorporeal membrane oxygenation

To evaluate and summarize the best evidence for early rehabilitation of adults with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Evidence on early rehabilitation of adult VV-ECMO patients was searched by computer from 7 English literature databases [PubMed database, cumulative index to nursing and allied health literature (CINAHL), Embase database, Cochrane library database, UpToDate clinical consultant, BMJ best clinical practice, JBI database], 5 Chinese literature databases (China biomedical literature database, China Yimai Tong, China national knowledge infrastructure, Wanfang data, VIP database), 5 guideline networks [National Institute for Health and Care Excellence (NICE), Scottish Intercollegiate Guidelines Network (SIGN), National Guideline Clearinghouse (NGC), Guidelines International Network (GIN), China Guide Network] and 2 professional association websites [Extracorporeal Life Support Organization (ELSO), Chinese Association of Rehabilitation Medicine]. The search period is from January 2011 to December 2021. The appraisal of guidelines for research and evaluation II (AGREE ) and JBI 2014 quality assessment tools were used to evaluate the quality of inclusion guidelines, systematic reviews, expert consensus and original studies, respectively, and to extract and summarize the best evidence for early rehabilitation of adults with VV-ECMO. A total of 2 guidelines, 2 expert consensuses, 2 systematic reviews and 8 original studies [including 1 randomized controlled trial (RCT), 1 non-randomized controlled study, 3 cohort studies and 3 case reports] were included. The evidence was summarized from 9 aspects including the necessity of early rehabilitation, rehabilitation initiation time, rehabilitation location, pre-rehabilitation preparation, pre-rehabilitation assessment, rehabilitation method, rehabilitation frequency and duration, rehabilitation process monitoring and effect evaluation,and finally 24 pieces of the best evidence were summarized. Early rehabilitation of adults with VV-ECMO is safe and feasible. The summary of the best evidence can provide evidence-based guidance for clinical medical staff to reasonably carry out early rehabilitation.

Stroke prevention of thoracoscopic left atrial appendage clipping in patients with non-valvular atrial fibrillation at high risk of stroke and bleeding: study protocol for a non-randomised controlled clinical trial

IntroductionNon-valvular atrial fibrillation (NVAF) is a high-risk factor for ischaemic stroke. The 2016 European Society of Cardiology Atrial Fibrillation Management guidelines recommend oral anticoagulants (OACs) to prevent stroke in men...

Elbow arthroplasty research methods, outcome domains, and instruments used in clinical outcome studies : a scoping review.

Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research. A scoping review was undertaken adhering to the Joanna Briggs Institute guidelines using Medline, Embase, CENTRAL, and trial registries, limited to studies published between 1 January 1990 and 7 February 2021. Endnote software was used for screening and selection, and included randomized trials, non-randomized controlled trials, prospective and retrospective cohort studies, case-control studies, analytical cross-sectional studies, and case series of ten or more patients reporting the clinical outcomes of elbow arthroplasty. The results are presented as the number of types of studies, sample size, length of follow-up, clinical outcome domains and instruments used, sources of funding, and a narrative review. A total of 362 studies met the inclusion criteria. Most were of total elbow arthroplasty (246; 68%), followed by radial head arthroplasty (100; 28%), distal humeral hemiarthroplasty (11; 3%), and radiocapitellar arthroplasty (5; 1%). Most were retrospective (326; 90%) and observational (315; 87%). The median sample size for all types of implant across all studies was 36 (interquartile range (IQR) 21 to 75). The median length of follow-up for all studies was 56 months (IQR 36 to 81). A total of 583 unique outcome descriptors were used and were categorized into 18 domains. A total of 105 instruments were used to measure 39 outcomes. We found that most of the literature dealing with elbow arthroplasty consists of retrospective observational studies with small sample sizes and short follow-up. Many outcomes have been used with many different instruments for their measurement, indicating a need to define a core set of outcomes and instruments for future research in this area.Cite this article: Bone Joint J2022;104-B(10):1148-1155.

Information System for Symptom Diagnosis and Improvement of Attention Deficit Hyperactivity Disorder: Protocol for a Nonrandomized Controlled Pilot Study.

BackgroundAttention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders during childhood; however, the diagnosis procedure remains challenging, as it is nonstandardized, multiparametric, and highly dependent on subjective evaluation of the perceived behavior.ObjectiveTo address the challenges of existing procedures for ADHD diagnosis, the ADHD360 project aims to develop a platform for (1) early detection of ADHD by assessing the user’s likelihood of having ADHD characteristics and (2) providing complementary training for ADHD management.MethodsA 2-phase nonrandomized controlled pilot study was designed to evaluate the ADHD360 platform, including ADHD and non-ADHD participants aged 7 to 16 years. At the first stage, an initial neuropsychological evaluation along with an interaction with the serious game developed (“Pizza on Time”) for approximately 30-45 minutes is performed. Subsequently, a 2-week behavior monitoring of the participants through the mADHD360 app is planned after a telephone conversation between the participants’ parents and the psychologist, where the existence of any behaviors characteristic of ADHD that affect daily functioning is assessed. Once behavior monitoring is complete, the research team invites the participants to the second stage, where they play the game for a mean duration of 10 weeks (2 times per week). Once the serious game is finished, a second round of behavior monitoring is performed following the same procedures as the initial one. During the study, gameplay data were collected and preprocessed. The protocol of the pilot trials was initially designed for in-person participation, but after the COVID-19 outbreak, it was adjusted for remote participation. State-of-the-art machine learning (ML) algorithms were used to analyze labeled gameplay data aiming to detect discriminative gameplay patterns among the 2 groups (ADHD and non-ADHD) and estimate a player’s likelihood of having ADHD characteristics. A schema including a train-test splitting with a 75:25 split ratio, k-fold cross-validation with k=3, an ML pipeline, and data evaluation were designed.ResultsA total of 43 participants were recruited for this study, where 18 were diagnosed with ADHD and the remaining 25 were controls. Initial neuropsychological assessment confirmed that the participants in the ADHD group showed a deviation from the participants without ADHD characteristics. A preliminary analysis of collected data consisting of 30 gameplay sessions showed that the trained ML models achieve high performance (ie, accuracy up to 0.85) in correctly predicting the users’ labels (ADHD or non-ADHD) from their gameplay session on the ADHD360 platform.ConclusionsADHD360 is characterized by its notable capacity to discriminate player gameplay behavior as either ADHD or non-ADHD. Therefore, the ADHD360 platform could be a valuable complementary tool for early ADHD detection.Trial RegistrationClinicalTrials.gov NCT04362982; https://clinicaltrials.gov/ct2/show/NCT04362982International Registered Report Identifier (IRRID)RR1-10.2196/40189

Effect of knee arthroscopy on subsequent total knee arthroplasty: Meta-analysis

To evaluate effect of knee arthroscopy on prognosis of subsequent total knee arthroplasty (total knee arthroplasty, TKA) by Meta-analysis. Databases including PubMed, Embase, Cochrane Library, CNKI, Wanfang and other databases were searched by computer from establishing to October 2020 to collect literatures on effect of knee arthroscopy on prognosis of subsequent TKA. Quality evaluation and data extraction were carried out according to inclusion, exclusion criteria and literature screening. Newcastle-Ottawa Scale (NOS) was used to evaluate literature quality of non-randomized controlled studies. RevMan 5.3 software was applied to Meta-analysis on revision rate, reoperation rate, postoperative stiffness rate, periprosthetic infection rate, postoperative venous thrombosis venous thromboembolism(VTE) rate and postoperative knee flexion range of motion after TKA. Eight literatures were finally included with totally sample size of 182 815 patients. Among them, 6 998 patients were in knee arthroscopy group and 175 817 patients were in knee arthroscopy group. Meta-analysis results showed that there were statistical differences in revision rate after TKA[OR=1.66, 95%CI(1.37, 2.00), P<0.000 01], re-operation rate[OR=2.31, 95%CI(1.59, 3.36), P<0.000 1], postoperative stiffness rate[OR=1.78, 95%CI(1.02, 3.11), P=0.04] and infection rate around prosthesis[OR=1.40, 95%CI(1.19, 1.66), P<0.000 1]. While there were no difference in VTE rate[OR=1.06, 95%CI(0.83, 1.35), P=0.64], postoperative knee flexion range of motion[MD=-1.21, 95%CI(-3.07, 0.65), P=0.20]. Knee arthroscopy has a negative impact on subsequent TKA surgery. Previous arthroscopic increased risk of stiffness, periprosthetic joint infection, revision and reoperation after TKA, but there was no significant difference in postoperative knee flexion range of motion and incidence of VTE.

Effects of physical rehabilitation on exercise tolerance in post-COVID patients: results of an open controlled trial

The issue of physical rehabilitation of post-COVID patients stays relevant up to this day. Most publications discuss inpatient rehabilitation and only few publications describe outpatient physical rehabilitation of such patients.The aim. Our study was performed to investigate efficacy of outpatient physical rehabilitation of post-COVID patients with lung injury.Methods. This was a prospective non-randomized open controlled study. All patients with COVID-19-associated lung injury were referred to supervised outpatient rehabilitation program. We analyzed 6-minute walk test (6-MWT) results, evaluation of dyspnea using Borg scale and assessment of oxygen saturation (SpO2) using pulse oxymeter before and after walking.Results. The rehabilitation group included 24 patients and the control group included 6 patients. The baseline and demographic findings did not differ significantly between the groups. The 6-minute distance (6-MWD) (р = 0.000018), heat rate at rest (р = 0.017) and after walking (р = 0.017), dyspnea after walking (р = 0.017), oxygen saturation at rest (р = 0.030) and after walking (р = 0.0021) improved significantly in the rehabilitation group and did not change significantly in the control group. At the end of the study, 6-MWD increased by 63.2 ± 36.3 m in the rehabilitation group compared to 14.0 ± 28.8 m in the control group (р = 0,01) and exertional dyspnea score increased by 0 (0 – 1) compared to 1 (1 – 2) in the control group (p = 0.033).Conclusion. Supervised outpatient physical rehabilitation in outpatient settings can accelerate physical recovery in post-COVID patients with lung injury.

Effectiveness of early essential newborn care on breastfeeding and maternal outcomes: a nonrandomized controlled study

BackgroundBreastfeeding and maternal health play crucial roles in improving newborn health, which is closely related to the development of families and society. Early essential newborn care, which emphasizes early exclusive breastfeeding and skin-to-skin contact, is recommended by the World Health Organization. This study aimed to explore the association of early essential newborn care with breastfeeding and maternal outcomes.MethodsA nonrandomized controlled study was carried out from May 2020 to January 2021 in a tertiary hospital in Chengdu city, China. Pregnant women were recruited from the maternity ward before they gave birth. Early essential newborn care was performed for 91 mother-newborn pairs after birth in the intervention group, while routine birth care was performed for 91 mother-newborn pairs in the control group. Data on breastfeeding and maternal outcomes were collected pre-test and post-test and were recorded by trained data collectors and retrieved from hospital case record files.ResultsCompared with the control group, the intervention group had a higher incidence of early breastfeeding initiation, an earlier initiation and longer duration for the first breastfeeding, a higher incidence of successful first breastfeeding, more exclusive breastfeeding at hospital discharge, higher maternal breastfeeding self-efficacy, a shorter duration of the third stage of labour, lower postpartum blood loss, and lower scores of maternal pain and anxiety postpartum; the differences were statistically significant (p < 0.05).ConclusionThe implementation of high-quality early essential newborn care can help mothers initiate early breastfeeding, improve exclusive breastfeeding rates at hospital discharge, enhance breastfeeding self-efficacy, promote the woman’s recovery from labour, and reduce maternal anxiety and pain in the postpartum period. High-quality early essential newborn care is recommended to policymakers and medical professionals to improve breastfeeding and maternal outcomes.Trial registrationChinese Clinical Trial Registry, Retrospective Registration (27/7/2021), registration number: ChiCTR2100049231.

Effect of Cholinesterase Inhibitors on Mortality in Patients With Dementia: A Systematic Review of Randomized and Nonrandomized Trials.

Cholinesterase inhibitors (ChEIs) have cardiovascular effects in addition to their neurologic activity and might alter mortality. We wanted to know whether treatment with ChEIs modifies mortality in patients with dementia. We searched PubMed, Embase, Cochrane CENTRAL, ClinicalTrials.gov, and ICRTP, from their inception to November 2021, and screened bibliographies of reviews, guidelines, and included studies. We included randomized controlled trials (RCTs) and nonrandomized controlled studies at lower risk of bias comparing ChEI treatment with placebo or usual treatment, for 6 months or longer, in patients with dementia of any type. Two investigators independently assessed studies for inclusion, assessed their risk of bias, and extracted data using predefined forms. Any discordance between investigators was solved by discussion and consensus. Data on all-cause and cardiovascular mortality, measured as either crude death rates or multivariate adjusted hazard ratios (HRs), were pooled using a random-effect model. Information size achieved was assessed using trial sequential analysis (TSA). We followed Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Twenty-four studies (12 RCTs, 12 cohorts, mean follow-up 6-120 months), cumulating 79,153 patients with Alzheimer (13 studies), Parkinson (1), vascular (1), or any type (9) dementia, fulfilled inclusion criteria. Pooled all-cause mortality in control patients was 15.1 per 100 person-years. Treatment with ChEIs was associated with lower all-cause mortality (unadjusted risk ratio [RR] 0.74, 95% CI 0.66-0.84; adjusted HR 0.77, 95% CI 0.70-0.84, moderate-quality to high-quality evidence). This result was consistent between randomized and nonrandomized studies and in several sensitivity analyses. No difference appeared between subgroups by type of dementia, age, individual drug, or dementia severity. Less data were available for cardiovascular mortality (3 RCTs, 2 cohorts, 9,182 patients, low-quality to moderate-quality evidence), which was also lower in patients treated with ChEIs (unadjusted RR 0.61, 95% CI 0.40-0.93, adjusted HR 0.47, 95% CI 0.32-0.68). In TSA analysis, the results for all-cause mortality were conclusive but not those for cardiovascular mortality. There is moderate-quality to high-quality evidence of a consistent association between long-term treatment with ChEIs and a reduction in all-cause mortality in patients with dementia. These findings may influence decisions to prescribe ChEIs in those patients. This systematic review was registered in the PROSPERO international prospective register of systematic reviews with the number CRD42021254458 (June 11, 2021).

Effectiveness of a specific physical therapy program for Charcot-Marie-Tooth on sleep quality, pain perception, and nocturnal cramps: a pilot study.

IntroductionChronic pain, nocturnal cramps, and sleep alterations are prevalent symptoms and signals in Charcot-Marie-Tooth disease patients. Sleep and pain are bidirectionally related and physical therapy can improve the binomial sleep and pain/nocturnal cramps. Therefore, we hypothesized that the application of a specific physical therapy program for Charcot-Marie-Tooth disease would improve sleep quality, pain perception, and nocturnal cramps.Material and MethodsA non-randomized controlled study that included 9 Charcot-Marie-Tooth disease patients (intervention group - physical therapy program) and 8 controls (active control group - booklet on sleep hygiene). The intervention lasted 8 weeks, three sessions per week. The effects were evaluated ten days before (baseline) and ten days after the intervention (post). Our primary outcome was sleep quality (subjective and objective, assessed by Pittsburgh sleep quality index and actigraphy, respectively); and secondary outcomes were pain perception (brief pain inventory) and nocturnal cramps (self-report).ResultsThe program was able to improve the subjective sleep quality (p=0.005) and nocturnal cramps (p<0.001) but had no effect on actigraphy data (p>0.05) neither on pain perception (p>0.05).ConclusionOur initial hypothesis was partially corroborated: the improvement in subjective quality of sleep and nocturnal cramps is already beneficial for the health promotion of the volunteers in this study affected by the disease. Our findings may serve as a basis for future research to develop a program focused on the treatment of analgesia, which can improve pain perception and alter the objective quality of sleep.