Nonrandomized Interventional Study Research Articles

Children with cancer and their cardiorespiratory fitness and physical function-the long-term effects of a physical activity program during treatment: a multicenter non-randomized controlled trial.

We aimed to determine the effects of a classmate-supported, supervised, in-hospital physical activity program during treatment primarily on cardiorespiratory fitness and secondarily on physical function. A multicenter non-randomized controlled intervention study including children diagnosed with cancer, 6-18 years at diagnosis treated with chemo-/radiotherapy. The intervention comprised (i) an educational session on cancer in the child's school class; (ii) selection of two "ambassadors"-classmates who were co-admitted, supporting the child's everyday hospital life; and (iii) supervised in-hospital physical activity from diagnosis and throughout intensive treatment. One-year post-treatment, physical testing included cardiorespiratory fitness (primary outcome), Sit-to-Stand test, Timed-Up-and-Go, and Handgrip Strength. The intervention group included 75 of 120 children (61% boys, 13.4 ± 3.1 years); the control groups included 33 of 58 children with cancer (58% boys, 13.5 ± 2.5 years), and 94 age- and sex-matched children without a cancer history. One-year post-treatment, cardiorespiratory fitness tended to be higher in the intervention group (37.0 ± 6.0 mL/kg/min) than in the patient control group with cancer (32.3 ± 9.7 mL/kg/min) (mean difference 4.7 [0.4 to 9.1], p = 0.034). The intervention group performed better in the secondary outcomes. Compared with community controls, bothpatient groups had lower cardiorespiratory fitness. The patient control group had lower Sit-to-Stand, Timed Up and Go, and Handgrip Strength, while the intervention group had strength comparable to that of the community controls. Peer-supported, supervised, in-hospital physical activity during treatment may improve cardiorespiratory fitness and muscle strength 1-year post-treatment in children with cancer; however, survivors continue to have lower cardiorespiratory fitness than community controls. Children with cancer may benefit from in-hospital physical activity in improving long-term cardiorespiratory fitness and muscle strength.

Effect of surgery-first approach on quality of life and mental health of orthognathic patients: A systematic review and meta-analysis

ObjectivesThis study intends to explore the effects of the surgery-first approach (SFA) on quality of life and mental health of patients who undergo orthognathic surgery compared to the conventional three-stage approach (CTA). DataThe analysis included eight studies with a total of 307 patients, of which one was randomized controlled trial (RCT), one was clinical controlled trial (CCT), and six were non-randomized studies of interventions (NRSIs). SourcesElectronic databases such as Medline, Embase, Scopus, and Web of Science were searched for eligible trials up to April 2023. Study selectionRCTs, CCTs, and NRSIs, which compared the quality of life or mental health of orthognathic patients treated with SFA and CTA, were included in this study. The meta-analysis showed that the standardized mean differences (SMD) of Oral Health Impact Profiles-14 (OHIP-14) scores and the Orthognathic Quality of Life Questionnaire (OQLQ) between SFA and CTA were −1.58 (P = 0.05) and −2.99 (P < 0.00001) at the termination of the first-stage treatment, which altered to −0.94 (P = 0.54) and 0.09 (P = 0.65) after total treatment. Two studies applied the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) and the Beck Depression Inventory (BDI-II) to examine mental health, resulting in a trend similar to the former scales. ConclusionIn contrast to the conventional procedure, orthognathic treatment with SFA can instantly enhance the quality of life at the end of the first-stage treatment but has similar effects after the overall treatment. Moreover, SFA has a positive impact on psychological conditions. Clinical significanceThis study first systematically reviewed the effect of SFA on patients' mental well-being. According to our findings, it is better to select SFA if possible. Otherwise, the patient's psychological condition should be monitored appropriately throughout decompensation for better well-being both physically and mentally.

Effect of Cochlear Implant Electrode Insertion Depth on Speech Perception Outcomes: A Systematic Review.

The suitable electrode array choice is broadly discussed in cochlear implantation surgery. Whether to use a shorter electrode length under the aim of structure preservation versus choosing a longer array to achieve a greater cochlear coverage is a matter of debate. The aim of this review is to identify the impact of the insertion depth of a cochlear implant (CI) electrode array on CI users' speech perception outcomes. PubMed was searched for English-language articles that were published in a peer-reviewed journal from 1997 to 2022. A systematic electronic search of the literature was carried out using PubMed to find relevant literature on the impact of insertion depth on speech perception. The review was conducted according to the preferred reporting items for systematic reviews and meta-analyses guidelines of reporting. Studies in both, children and adults with pre- or postlingual hearing loss, implanted with a CI were included in this study. Articles written in languages other than English, literature reviews, meta-analyses, animal studies, histopathological studies, or studies pertaining exclusively to imaging modalities without reporting correlations between insertion depth and speech outcomes were excluded. The risk of bias was determined using the "Risk of Bias in Nonrandomized Studies of Interventions" tool. Articles were extracted by 2 authors independently using predefined search terms. The titles and abstracts were screened manually to identify studies that potentially meet the inclusion criteria. The extracted information included: the study population, type of hearing loss, outcomes reported, devices used, speech perception outcomes, insertion depth (linear insertion depth and/or the angular insertion depth), and correlation between insertion depth and the speech perception outcomes. A total of 215 relevant studies were assessed for eligibility. Twenty-three studies met the inclusion criteria and were analyzed further. Seven studies found no significant correlation between insertion depth and speech perception outcomes. Fifteen found either a significant positive correlation or a positive effect between insertion depth and speech perception. Only 1 study found a significant negative correlation between insertion depth and speech perception outcomes. Although most studies reported a positive effect of insertion depth on speech perception outcomes, one-third of the identified studies reported no correlation. Thus, the insertion depth must be considered as a contributing factor to speech perception rather than as a major decisive criterion. This review has been registered in PROSPERO, the international prospective register of systematic reviews (CRD42021257547), available at https://www.crd.york.ac.uk/PROSPERO/.

Quality of life with minimally invasive repair of pectus excavatum: a systematic review and meta-analysis.

Minimally invasive repair of pectus excavatum (MIRPE) is a popular method for surgical correction of PE, and its impact on quality of life is a growing area of interest. We performed a systematic review and meta-analysis to evaluate the impact of MIRPE on the quality of life of patients. This study was registered with PROSPERO under reference number CRD42020222061. A literature search of PubMed, Cochrane Library, EMBASE and Scopus was conducted from the date of inception till November 23, 2020. We included studies which administered one or more questionnaires on patients up to 60 years old, parents or both, to assess the quality of life before and after MIRPE. Studies not written in English, abstracts, articles without primary data, reviews and studies which combined data on PE and other deformities were excluded. Risk of bias was assessed using the Risk of Bias in Non-randomised Studies of Interventions and the Cochrane risk of bias tool. A random-effects meta-analysis was performed to obtain mean differences for key themes of quality of life before and after MIRPE. Responses from the same questionnaires, as well as common themes across different questionnaires, were compared. Of the 20 studies identified for systematic review, 7 studies that reported the responses of 478 patients were included in the meta-analysis. Patients who underwent MIRPE experienced an increased self-esteem [standardized mean difference (SMD): 1.38, 95% confidence interval (CI): 0.95 to 1.81, P<0.00001] and a smaller degree of chest interference with their social activities (SMD: 0.84, 95% CI: 0.60 to 1.08, P<0.00001). These findings were consistent even after the implanted bar was removed. MIRPE may be associated with a better quality of life for patients with PE as self-esteem and extent of chest interference with social activities are improved after the procedure. The key limitations of this study are the lack of high-quality evidence due to paucity of randomized trials, and the significant heterogeneity in reported outcomes due to variations in the questionnaires and timepoints of administration.

A Systematic Review and Meta Analysis of Non-Randomized Interventional Studies on the Pamidronate Treatment Efficacy for Patients with Bone Fibrous Dysplasia

Objective: Pamidronate is one of the main therapies for Fibrous Dysplasia (FD), with documented enhancements in patients' clinical characteristics. Nevertheless, its usage has yielded inconclusive results. Therefore, this review aimed to investigate pamidronate’s impact on several clinical and biochemical outcomes in FD patients. Materials and Methods: This review was conducted under the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, ProQuest, Wiley, and EBSCO search databases were used to search the literature. Risk of Bias In Non-Randomized Studies of Interventions (ROBINS-I) was applied for quality assessment of the included studies and Review Manager (RevMan) 5.4 was employed in performing the meta-analysis. Results: There are eight and seven studies used in the meta-analysis and systematic review, respectively. The results showed there are two studies with a low risk of bias and six with a moderate category. All papers included in this meta-analysis showed significant differences in the reduction of bone pain (p&lt;0.00001) and serum alkaline phosphatase (SAP) (p=0.04) after pamidronate treatment compared to the before-treatment groups. Conclusion: The findings of this study indicated that pamidronate therapy had been proven to significantly reduce bone pain and increase SAP in FD patients. However, trials with more age-specific samples and a lower risk of bias should be carried out to determine the statistical significance of overall results.

Outcomes comparison of testicular versus ejaculated sperm for intracytoplasmic sperm injection in infertile men with high DNA fragmentation: updated systematic review and meta-analysis.

The testicular sperm instead of ejaculated sperm for intracytoplasmic sperm injection (ICSI) in infertile men with high sperm DNA fragmentation (SDF) is a controversial topic. This updated systematic review and meta-analysis aims to evaluate whether couples with high level of SDF will benefit more from intracytoplasmic sperm injection with testicular sperm (Testi-ICSI) as compared to intracytoplasmic sperm injection with ejaculated sperm (Ejac-ICSI). A systematic search was conducted according to PRISMA guidelines, using PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials (CENTRAL), encompassing studies from the earliest record until May 2022. We included studies analyzing comparative pregnancy outcomes of testicular versus ejaculated sperm for ICSI in infertile men with high DNA fragmentation. The risks of bias and certainty of evidence were assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework, respectively. Eleven studies were included. Meta-analysis showed that SDF levels revealed a significant difference association [odds ratio (OR) =-25.81; 95% confidence interval (CI): -34.82, -16.81; I2=94%; P<0.00001] between testicular and ejaculated sperm. Compared with Ejac-ICSI, a non-significant tendency was observed for fertilization rates (FRs) in the Testi-ICSI group (OR =0.87; 95% CI: 0.67, 1.12; I2=81%; P=0.28). However, there was significant difference pointing to better outcomes for Testi-ICSI in clinical pregnancy rates (CPRs) (OR =2.36; 95% CI: 1.71, 3.24; I2=0%; P<0.00001), live birth rates (LBRs) (OR =3.10; 95% CI: 2.13, 4.51; I2=4%; P<0.00001) and miscarriage rates (MRs) (OR =0.28; 95% CI: 0.13, 0.60; I2=0%; P=0.001). Results of this updated meta-analysis reveal that SDF rates are lower in testicular sperm than in ejaculated sperm and that Testi-ICSI is correlated with better clinical outcomes, including higher CPRs, higher LBRs, and lower MRs in infertile males with high SDF levels. Nevertheless, with the overall low to moderate quality of the studies, further well-designed controlled studies are required.

The moderating and mediating role of eating behaviour traits in acceptance and commitment therapy-based weight management interventions: protocol for an individual participant data meta-analysis

IntroductionPrecision medicine approaches to obesity aim to maximise treatment effectiveness by matching weight management interventions (WMIs) to characteristics of individuals, such as eating behaviour traits (EBTs). Acceptance and commitment therapy...

The Effects of Auricular Therapy in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis

Purpose: This systematic review and meta-analysis aimed to examine the effects of auricular therapy on alleviating indicators of disease status in patients with type 2 diabetes. Methods: A comprehensive literature search was conducted in the PubMed, Scopus, and Cochrane Library databases using relevant search terms. The quality of the included studies was assessed using the Cochrane Risk of Bias tool for randomized controlled trials and the Risk of Bias tool for non-randomized studies of interventions. Results: Ten studies were included for the systematic review. Most of the studies were conducted in Asia, and randomized controlled trials were primarily chosen as the study design. The auricular therapy points most commonly used were related to the pancreas, which is associated with diabetes. A meta-analysis using a random-effects model to analyze glycated hemoglobin showed a Hedges' g value of -0.11 (95% CI: -0.53 to 0.32, &lt;i&gt;p&lt;/i&gt;=.623), which was not statistically significant. However, the standardized mean difference for fasting blood sugar was -0.97 (95% CI=-1.22 to -0.72, &lt;i&gt;p&lt;/i&gt;&lt;.001), indicating a large and statistically significant effect size. Conclusion: The results of this study indicate that auricular therapy may have an impact on fasting blood sugar levels. However, the studies used in this analysis were limited and some publication bias was identified, requiring further research to determine the broader implications and effectiveness of auricular therapy

Omega-3 Fatty Acid Supplements in Reducing Vaso-Occlusive Crisis Hospitalizations in Patients with Sickle Cell Disease: A Systemic Review and Meta-Analysis

Introduction Omega-3 fatty acids (O3FA) have been evaluated in various clinical settings for sickle cell disease (SCD) patients with promising results. This study aims to assess the efficacy and safety of O3FA supplements in preventing SCD complications. Methods We systematically searched Embase, PubMed, and Cochrane Register of Controlled Trials from inception to May 26 th, 2023. Studies that met the following criteria were included: (1) randomized controlled trials (RCTs) or nonrandomized studies of interventions; (2) comparing O3FA supplements to the standard of care (with or without hydroxyurea treatment); (3) patients with sickle cell disease; (4) and reporting at least one clinical outcomes of interest. We excluded studies (1) with unstable treatment history 3-6 months before the beginning of the studies; or (2) with patients on regular blood transfusion. Our outcomes of interest included (1) the frequency of painful vaso-occlusive crisis or acute chest syndrome requiring hospitalization; and (2) hemoglobin level after intervention. We used Review manager software to perform statistical analyses. The random effect model was applied to all analyses due to anticipated heterogeneity. Pooled mean differences and 95% confidence intervals (CI) were used to assess outcomes. Results We screened 188 studies and included four RCTs and one self-controlled cohort in the meta-analysis. Our population included 349 patients aged between 2 years to adults; 54.7% received O3FA supplements. The docosahexaenoic acid (DHA) dose ranged from 10 to 60 mg per kilogram daily. Follow-up varied from 3 to 12 months. More than two-thirds were hemoglobin SS disease, as presented in Table 1. Other SCD syndromes included hemoglobin S-beta 0 thalassemia and hemoglobin SC disease. Severe baseline disease (³ 3 episodes of painful vaso-occlusive crisis per year requiring hospital admission) ranged between 23.5% and all patients among studies. The vaso-occlusive crisis episodes were significantly reduced in the O3FA group compared with standard treatment: mean difference (MD)-1.63 times (95% CI: -2.35 to -0.91; p = 0.00001; I 2 = 54%), as seen in Figure 1a. There was no difference in hemoglobin levels after intervention with O3FA versus standard treatment (MD: 0.03; 95% CI: -0.25 to 0.32; p = 0.82). In the subgroup of patients without hydroxyurea treatment, the mean frequency of vaso-occlusive crisis was significantly lower with O3FA supplements compared with standard treatment (MD: -1.60; 95% CI: -2.47 to -0.72; p = 0.0004; I 2 = 67%), as shown in Figure 1b. There were no significant adverse events (AE) in the O3FA group. The most common AE were increased appetite, dyspepsia, and occasional “fishy” smell. One patient discontinued O3FA supplements because of drug-related abdominal pain. Conclusion Our systematic review and meta-analysis support O3FA supplementation as a safe and effective complementary strategy to reduce painful vaso-occlusive crises in patients with SCD.

Efficacy of mHealth Interventions for Improving Maternal and Neonatal Outcomes Among Pregnant Women With Hypertensive Disorders: Protocol for a Systematic Review.

Hypertension is one of the most prevalent medical conditions that arise during pregnancy, resulting in maternal and neonatal complications. Mobile health (mHealth) has emerged as an innovative intervention for delivering maternal and child health care services. The evidence on the effectiveness of mHealth interventions in improving the health outcomes of pregnant women with hypertensive disorders is lacking. Therefore, there is a need for evidence synthesis using systematic review methods to address this evidence gap. This review aims to determine the efficacy of mHealth interventions in improving maternal and neonatal outcomes among pregnant women with hypertensive disorders. The review will answer the following research questions: (1) What are the types of mHealth interventions used in pregnant women with hypertensive disorders? (2) Are the various mHealth interventions effective in improving maternal and neonatal health outcomes, health behaviors, and their knowledge of the disease? and (3) Are mHealth interventions effective in supporting health care providers to make health care decisions for pregnant women with hypertensive disorders? This review will include randomized controlled trials, nonrandomized controlled trials, and cohort studies focusing on mHealth interventions for pregnant women with hypertensive disorders. Studies reporting health care providers use of mHealth interventions in caring for pregnant women with hypertensive disorders will be included. The search strategy will be tailored to each database using database-specific search terms. The search will be conducted in PubMed-MEDLINE, ProQuest, CINAHL, Scopus, Web of Science, and CENTRAL. Other literature sources, such as trial registries and bibliographies of relevant studies, will be additionally searched. Studies published in English from January 2000 to January 2023 will be included. A total of 2 review authors will independently perform the data extraction and the quality appraisal. For quality appraisal of randomized controlled trials, the Cochrane Risk of Bias 2 tool will be used. The Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-1) tool will be used for nonrandomized controlled trials, and the Critical Appraisal Skills Programme checklist for cohort studies will be used. Any disagreements between the 2 reviewers will be resolved through discussion and a third reviewer if required. A meta-analysis will be performed based on the availability of the data. As per the protocol, the study methodology was followed, and 2 independent reviewers conducted the search in 6 databases and clinical registries. Currently, the review is in the full-text screening stage. The review will publish the results in the first quarter of 2024. The evidence synthesized from this systematic review will help guide future research, support health care decisions, and inform policy makers on the effectiveness of mHealth interventions in improving the maternal and neonatal outcomes of pregnant women with hypertensive disorders. PRR1-10.2196/51792.

Neuroprotective Effects of Moderate Hypoxia: A Systematic Review.

Emerging evidence highlights moderate hypoxia as a candidate treatment for brain disorders. This systematic review examines findings and the methodological quality of studies investigating hypoxia (10-16% O2) for ≥14 days in humans, as well as the neurobiological mechanisms triggered by hypoxia in animals, and suggests optimal treatment protocols to guide future studies. We followed the preferred reporting items for systematic reviews and meta-analysis (PRISMA) 2020. Searches were performed on PubMed/MEDLINE, PsycInfo, EMBASE, and the Cochrane Library, in May-September 2023. Two authors independently reviewed the human studies with the following tools: (1) revised Cochrane collaboration's risk of bias for randomized trials 2.0; (2) the risk of bias in nonrandomized studies of interventions. We identified 58 eligible studies (k = 8 human studies with N = 274 individuals; k = 48 animal studies) reporting the effects of hypoxia on cognition, motor function, neuroimaging, neuronal/synaptic morphology, inflammation, oxidative stress, erythropoietin, neurotrophins, and Alzheimer's disease markers. A total of 75% of human studies indicated cognitive and/or neurological benefits, although all studies were evaluated ashigh risk of bias due to a lack of randomization and assessor blinding. Low-dose intermittent or continuous hypoxia repeated for 30-240 min sessions, preferably in combination with motor-cognitive training, produced beneficial effects, and high-dose hypoxia with longer (≥6 h) durations and chronic exposure produced more adverse effects. Larger and methodologically stronger translational studies are warranted.

The clinical effectiveness of waxing or epilation compared with other methods of hair removal in reducing the incidence of surgical site infections: a protocol for a systematic review

Background: Surgical site infections (SSIs) represent a significant challenge in healthcare, contributing to morbidity, mortality as well as economic burden. Traditional preoperative methods of hair removal are under scrutiny, with some methods potentiality increasing the risk of SSIs. This systematic literature review (SLR) protocol outlines the assessment of the clinical effectiveness of waxing and epilation compared with other methods of hair removal in reducing SSIs. Methods: Using PRISMA guidelines and the Joanna Briggs Institute Evidence Synthesis Checklist, this review aims to evaluate all interventional and observational studies that compare waxing or epilation against other methods or, indeed, no hair removal. The SLR has been prospectively registered with PROSPERO (ref: CRD42023423798). A comprehensive search strategy across Medline, Embase, CENTRAL, Clinicaltrials.Gov and CINAHL is planned, complemented by handsearching references of key articles. Important inclusion criteria include adult patient population, English language studies, and SSI reporting at 30 days. Both the Cochrane Risk of Bias (RoB2) tool and Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool will be employed. Data extraction will include study characteristics, participant characteristics,intervention and comparator details, and primary outcome data. The primary outcome is overall incidence of SSIs and, if feasible, a quantitative analysis including meta-analysis will be performed. Discussion: This review has the potential to fill a knowledge gap around waxing and epilation as methods of preoperative hair removal, examining their impact on SSI incidence. These techniques offer theoretical advantages, such as extended hair-free periods and possible promotion of wound healing, but also have potential risks due to increased microtrauma. Due to the paucity of high-level evidence, there is a lack of consensus around their use. The outcomes of this review could reaffirm current guidelines or guide future practices. The high incidence of SSIs in areas like vascular surgery highlights the therapeutic potential of new evidence. One limitation of the study might be the small volume of literature on the subject, which could decrease statistical analysis power and make quantitative comparison challenging. If no high-quality evidence is found, this would indicate an unexplored area, potentially informing the design of primary research into waxing and epilation as SSI prevention methods. Conclusion: This protocol lays the foundation for a comprehensive review of the clinical effectiveness of waxing and epilation in the prevention of SSIs. The insights gained could shape current clinical practice, influence guidelines or guide future research, ultimately contributing to the reduction of the substantial burden of SSIs.

Changes in functional health status following open abdominal aortic aneurysm repair and the role of exercise-based rehabilitation: a systematic review

Background: Physical domains of quality of life measures are negatively impacted following abdominal aortic aneurysm (AAA) repair. This is likely to reflect a reduction in objective measures of functional status, although this is yet to be established. These reductions can be targeted via exercise-based rehabilitation. This review aims to systematically evaluate the current evidence quantifying changes in functional status following open AAA repair and to consider the role of exercise-based rehabilitation for these patients. Methods: The Medline, EMBASE and Cochrane CENTRAL databases were searched using two distinct search strategies. We included all prospective randomised and non-randomised trials that considered the impact of open AAA repair on functional status and/or the effect of exercise-based rehabilitation following open AAA repair. The primary outcomes were changes in objective measures of functional status following AAA repair and changes in these measures following exercise-based rehabilitation. Risk of bias was independently assessed by two review authors using the criteria outlined in the revised Cochrane tool (ROB 2.0) or the risk of bias in non-randomised studies of interventions (ROBINS-I) tool. Results: No studies were identified that quantified changes in functional status following open AAA repair. One study considered exercise-based rehabilitation. This three-arm randomised trial compared two walking-based exercise programmes with routine care physiotherapy.Patients who underwent backward walking-based rehabilitation had a significantly lesser decline in functional status than the other groups, based on the 6-minute walk test and standard metabolic equivalents. There were no significant differences in length of stay or pulmonary function. Discussion: This is the first systematic review to explore the objective decline in functional status and the role of exercise-based rehabilitation following open AAA repair. There is no evidence to quantify functional decline following AAA repair and limited low quality evidence to support exercise-based rehabilitation. The ideal next step for future research would be a feasibility or observational before-and-after cohort study using direct measures of physical function such as the short physical performance battery or the 6-minute walk test.

The Impact of Bariatric Surgery on Weight Loss and Glycemic Control in Patients With Obesity and Type 2 Diabetes: A Systematic Review.

Obesity and type 2 diabetes mellitus (T2DM) are global health challenges. Bariatric surgery has emerged as a potential intervention for managing these conditions, but its efficacy and impact need comprehensive evaluation.This systematic review aimed to assess the impact of bariatric surgery on weight loss and glycemic control in patients with obesity and T2DM. FollowingPreferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic search was conducted in October 2023, primarily using PubMed. Studies were selected based on specific inclusion and exclusion criteria, focusing on bariatric surgery's relationship with weight loss and glycemic control. The quality of the included studies was assessed using the ROBINS-I (risk of bias in non-randomized studies of interventions) risk of bias assessment approach. Out of 272 initially identified studies, nine met the inclusion criteria. These studies, encompassing 10,445 participants from various global locations, predominantly targeted middle-aged participants. The findings consistently highlighted the benefits of bariatric surgery in weight reduction and improved glycemic control. However, the degree of benefits varied based on the type of surgical procedure, patient's BMI, and other individual factors. Bariatric surgery offers significant advantages in managing obesity and T2DM. While it consistently aids in weight reduction and glycemic control, individualized treatment approaches considering various patient and procedural factors are crucial for optimal outcomes. When applied to the right patient, bariatric surgery can offer significantly better glycemic control and weight reduction when compared to only medication control and lifestyle adjustments. However, future research should focus on long-term outcomes and the integration of surgical interventions with lifestyle and medical management.

Are e-Health Interventions Effective in Reducing Diabetes-Related Distress and Depression in Patients with Type 2 Diabetes? A Systematic Review with Meta-Analysis.

Background: e-Health refers to any health care service delivered through the internet or related technologies, to improve quality of life. Despite the increasing use of e-health interventions to manage type 2 diabetes (T2D), there is a lack of evidence about the effectiveness on diabetes distress and depression, which are common issues in those living with T2D. Purpose: To synthesize and determine the effects of e-health interventions on diabetes distress and depression among patients with T2D. Methods: We systematically searched PubMed, Scopus, Cochrane CENTRAL, and Web of Science for randomized controlled trials (RCTs), non-RCTs and observational cohort studies for the effects of e-health interventions on diabetes distress and depression in patients with T2D up to September 14, 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 recommendations were followed. The risk of bias was assessed according to the Risk-of-Bias 2 tool (RCTs), the Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I) (non-RCTs) and the National Institute of Health tool (observational). The standardized mean difference (SMD) and its related 95% confidence intervals (CIs) were estimated with the DerSimonian-Laird method through random-effect models. A pooled raw mean difference (MD) meta-analysis was conducted for RCTs comparing the effects of e-health versus control on diabetes distress screening to display the clinical impact. Results: A total of 41 studies (24 RCTs, 14 non-RCTs, and 3 observational) involving 8,667 individuals were included. The pooled SMD for the effect of e-health versus the control group on diabetes distress was -0.14 (95% CI = -0.24 to -0.04; I2 = 23.9%; n = 10 studies), being -0.06 (95% CI = -0.15 to 0.02; I2 = 7.8%; n = 16 studies) for depression. The pooled raw MD on diabetes distress screening showed a reduction of -0.54 points (95% CI = -0.81 to -0.27; I2 = 85.1%; n = 7 studies). Conclusion: e-Health interventions are effective in diminishing diabetes distress among adults with T2D, inducing clinically meaningful reductions.

Effectiveness of holistic mobile health interventions on diet, and physical, and mental health outcomes: a systematic review and meta-analysis

Good physical and mental health are essential for healthy ageing. Holistic mobile health (mHealth) interventions-including at least three components: physical activity, diet, and mental health-could support both physical and mental health and be scaled to the population level. This review aims to describe the characteristics of holistic mHealth interventions and their effects on related behavioural and health outcomes among adults from the general population. In this systematic review and meta-analysis, we searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, Scopus, China National Knowledge Infrastructure, and Google Scholar (first 200 records). The initial search covered January 1, 2011, to April 13, 2022, and an updated search extended from April 13, 2022 to August 30, 2023. Randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) were included if they (i) were delivered via mHealth technologies, (ii) included content on physical activity, diet, and mental health, and (iii) targeted adults (≥18 years old) from the general population or those at risk of non-communicable diseases (NCDs) or mental disorders. Studies were excluded if they targeted pregnant women (due to distinct physiological responses), individuals with pre-existing NCDs or mental disorders (to emphasise prevention), or primarily utilised web, email, or structured phone support (to focus on mobile technologies without exclusive human support). Data (summary data from published reports) extraction and risk-of-bias assessment were completed by two reviewers using a standard template and Cochrane risk-of-bias tools, respectively. Narrative syntheses were conducted for all studies, and random-effects models were used in the meta-analyses to estimate the pooled effect of interventions for outcomes with comparable data in the RCTs. The study was registered in PROSPERO, CRD42022315166. After screening 5488 identified records, 34 studies (25 RCTs and 9 pre-post NRSIs) reported in 43 articles with 5691 participants (mean age 39 years, SD 12.5) were included. Most (91.2%, n = 31/34) were conducted in high-income countries. The median intervention duration was 3 months, and only 23.5% (n=8/34) of studies reported follow-up data. Mobile applications, short-message services, and mobile device-compatible websites were the most common mHealth delivery modes; 47.1% (n=16/34) studies used multiple mHealth delivery modes. Of 15 studies reporting on weight change, 9 showed significant reductions (6 targeted on individuals with overweight or obesity), and in 10 studies reporting perceived stress levels, 4 found significant reductions (all targeted on general adults). In the meta-analysis, holistic mHealth interventions were associated with significant weight loss (9 RCTs; mean difference-1.70kg, 95% CI-2.45 to-0.95; I2=89.00%) and a significant reduction in perceived stress levels (6 RCTs; standardised mean difference [SMD]-0.32; 95% CI-0.52 to-0.12; I2=14.52%). There were no significant intervention effects on self-reported moderate-to-vigorous physical activity (5 RCTs; SMD 0.21; 95%CI-0.25 to 0.67; I2=74.28%) or diet quality scores (5 RCTs; SMD 0.21; 95%CI-0.47 to 0.65; I2=62.27%). All NRSIs were labelled as having a serious risk of bias overall; 56% (n=14/25) of RCTs were classified as having some concerns, and the others as having a high risk of bias. Findings from identified studies suggest that holistic mHealth interventions may aid reductions in weight and in perceived stress levels, with small to medium effect sizes. The observed effects on diet quality scores and self-reported moderate-to-vigorous physical activity were less clear and require more research. High-quality RCTs with longer follow-up durations are needed to provide more robust evidence. To promote population health, future research should focus on vulnerable populations and those in middle- and low-income countries. Optimal combinations of delivery modes and components to improve efficacy and sustain long-term effects should also be explored. National Research Foundation, Prime Minister's Office, Singapore, under its Campus for Research Excellence and Technological Enterprise (CREATE) Programme and Physical Activity and Nutrition Determinants in Asia (PANDA) Research Programme.

Distance simulation in the health professions: a scoping review

BackgroundDistance simulation is defined as simulation experiences in which participants and/or facilitators are separated from each other by geographic distance and/or time. The use of distance simulation as an education technique expanded rapidly with the recent COVID-19 pandemic, with a concomitant increase in scholarly work.MethodsA scoping review was performed to review and characterize the distance simulation literature. With the assistance of an informationist, the literature was systematically searched. Each abstract was reviewed by two researchers and disagreements were addressed by consensus. Risk of bias of the included studies was evaluated using the Risk of Bias 2 (RoB 2) and Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tools.ResultsSix thousand nine hundred sixty-nine abstracts were screened, ultimately leading to 124 papers in the final dataset for extraction. A variety of simulation modalities, contexts, and distance simulation technologies were identified, with activities covering a range of content areas. Only 72 papers presented outcomes and sufficient detail to be analyzed for risk of bias. Most studies had moderate to high risk of bias, most commonly related to confounding factors, intervention classification, or measurement of outcomes.ConclusionsMost of the papers reviewed during the more than 20-year time period captured in this study presented early work or low-level outcomes. More standardization around reporting is needed to facilitate a clear and shared understanding of future distance simulation research. As the broader simulation community gains more experience with distance simulation, more studies are needed to inform when and how it should be used.

The Performance of Primary Dual-Mobility Total Hip Arthroplasty in Patients Aged 55 Years and Younger: A Systematic Review

BackgroundDual-mobility (DM) total hip arthroplasty (THA) combines the stabilization advantage provided by large head articulation with the low friction advantage provided by small head articulation. There is momentum for DM to be used in a wider selection of patients, with some advocating for DM to be the routine primary total hip construct. Further investigation is needed to determine whether the use of DM in younger adults is validated by aggregate data. Our objective was to review the literature for the clinical performance of DM THA in patients aged 55 years and younger. MethodsA systematic review of the literature was performed according to the guidelines of Preferred Reporting in Systematic Reviews and Meta-Analyses. Inclusion in the review required clinical outcome reporting for DM primary THA in ambulatory patients aged 55 years or younger. The risk of bias was appraised using the Cochrane risk of bias in nonrandomized studies of interventions and the quality of the evidence was appraised using the Grading of Recommendations Assessment, Development and Evaluation framework. ResultsAcross a sample of 1048 cases, the frequency weighted term of follow-up was 87.7 months. The pooled rate of revision was 9.5%. The Harris Hip Score significantly improved from 49.1 preoperatively to 93 postoperatively. The Postel-Merle d'Aubigné score significantly improved from 10.5 preoperatively to 17.1 postoperatively. ConclusionsThe literature demonstrates satisfactory short-term outcomes with a mitigated risk of dislocation for DM used as primary THA in patients aged 55 years and younger. The current findings suggest that third-generation designs provide reduced rates of intraprosthetic dislocation and improved survivorship.

Immunosuppressive Therapy and Nutritional Status of Patients after Kidney Transplantation: A Protocol for a Systematic Review.

(1) Background: Kidney transplantation is widely recognized as the most effective method of treating end-stage renal disease. Immunosuppressive therapy plays a pivotal role in the treatment of kidney transplant patients, encompassing all patients (except identical twins), and is administered from organ transplantation until the end of its function. The aim of this systematic review is to identify the evidence of the association between immunosuppressive therapy and nutritional status of patients following kidney transplantation. (2) Methods: This protocol has been designed in line with Preferred Items for Systematic Reviews (PRISMA-P). Our search encompasses several databases, including MEDLINE (via PubMed), EMBASE (Elsevier), Scopus and Web of Science. We intend to include observational studies (cross-sectional, case-control, and cohort designs), randomized controlled trials (RCTs), as well as completed and ongoing non-randomized study designs. We will confine our search to studies published in English within the past decade (from inception to 17 February 2023). Qualitative studies, case studies, and conference reports will be excluded. The selection process will be done in Covidence by two independent reviewers. Data extraction will be conducted using a standardized MS Excel template version 16.0. Quality assessment of included studies will be performed using the Cochrane Risk of Bias tool for randomized trials (RoB2), or the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool. Risk-of-bias plots will be generated using the web application Robvis. Relevant data that have been extracted from eligible studies will be presented in a narrative synthesis. We expect the studies to be too heterogeneous to perform subgroup analyses. (3) Conclusion: This systematic review will offer insights into the evidence regarding association between immunosuppressive therapy and nutritional status of adult patients (18 years of age or older) within the initial year following kidney transplantation. To our knowledge, there is no systematic review addressing that question.

Evaluating risk of bias using ROBINS-I tool in nonrandomized studies of adjuvanted influenza vaccine

Seasonal variation in influenza vaccine effectiveness (VE) makes real-world evidence (RWE) useful in supplementing the clinical-evidence base from randomized clinical trials. Adjuvanted inactivated influenza vaccine (aIIV) VE has been evaluated in multiple nonrandomized RWE studies. A systematic literature review of RWE studies evaluating the absolute or relative VE of aIIV was conducted. Identified studies were assessed by evaluators for risk of bias (RoB) by means of the ROBINS-I (Reduction of Bias In Non-randomized Studies of Interventions) tool to inform evidence-based medicine deliberations. Differences in evaluator assessments were resolved by consensus. The literature review yielded 14 follow-up studies, seven test-negative case-control (TNCC) studies, five traditional case-control studies, and one cluster-randomized clinical trial. Most follow-up studies and three TNCC studies were judged at low RoB. Issues increasing RoB included inadequate control of confounding, selection of controls, and reliance on recall of vaccination. The concerns identified in any of the designs could be mitigated with straightforward revisions to design or implementation. 17 of 27 nonrandomized studies of adjuvanted influenza-vaccine effectiveness, some from each of four study designs, were judged at low risk of material bias. These studies merit credence in assessing aIIV effectiveness relative to other influenza vaccines.