Non-randomized Controlled Study Research Articles

The effectiveness of a co-management care model on older hip fracture patients in China – A multicentre non-randomised controlled study

SummaryBackgroundClinical guidelines recommend orthogeriatric care to improve older hip fracture patients’ outcomes, but few studies have been conducted in China. This study evaluated the effects of an orthogeriatric co-management care model in six Chinese hospitals.MethodsThis non-randomised controlled study was designed as an exploratory trial and was conducted in 3 urban and 3 suburban hospitals. Eligible patients were aged ≥ 65 years with X-ray confirmed hip fracture and admitted to hospital within 21 days of injury. All patients received three times follow-ups within one year (1-month, 4-month and 12-month post admission). Co-management care was implemented in 1 urban hospital, while usual care continued in 5 urban and suburban hospitals. Patient demographics, pre-, peri- and post-operative information, complications and mortality were collected at baseline and follow-ups. The primary outcome was proportion of patients receiving surgery within 48 hours from ward arrival. Secondary outcomes included osteoporosis assessment, in-hospital rehabilitation, length of hospital stay, in-hospital mortality and one-year cumulative mortality.FindingsThere were 2,071 eligible patients enrolled (1,110 intervention, 961 control). Compared to usual care, a significantly higher proportion of intervention patients received surgery within 48 hours (75% vs 27%, p<0.0001), osteoporosis assessment (99.9% vs 60.6%, p<0.0001), rehabilitation (99.1% vs 3.9%, p<0.0001) and shorter length of hospital stay (6.1 days vs 12.0 days, p<0.0001). The intervention group saw a significant lower in-hospital mortality rate than the control group (adjusted relative risk 0.021, 95% CI 0.001 to 0.45, P=0.01). One-year cumulative mortality was also significantly reduced in the intervention group (hazard ratio 0.59, 95% CI 0.38 to 0.80, p=0.01).InterpretationCo-management care of older hip fracture patients resulted in better outcomes, including decreased time to surgery, improved clinical management, and reduced one-year mortality. A randomised controlled trial is needed to provide definitive evidence.FundingThe study is supported by Capital's Funds for Health Improvement and Research (2018-1-2071).

Effects of regional citrate anticoagulation in continuous veno-venous hemofiltration of severe burn patients

Objective: To investigate the effects of regional citrate anticoagulation in continuous veno-venous hemofiltration (CVVH) of severe burn patients. Methods: A retrospective non-randomized controlled study was conducted. From January 2017 to August 2020, sixty-eight severe burn patients who met the inclusion criteria were treated with CVVH in Affiliated Hospital of Nankai University. According to the different methods of blood anticoagulation in CVVH treatment, patients were divided into citrate group (n=40) and heparin group (n=28). In the citrate group, 32 males and 8 females were (40±18) years old with total burn area of (62±14)% total body surface area (TBSA); in the heparin group, 22 males and 6 females were (38±16) years old with total burn area of (57±20)%TBSA. Creatinine level, C-reactive protein (CRP) value, and urea nitrogen level in serum of patients were recorded at 0 (immediately), 48, and 96 h after CVVH treatment in 2 groups, urea clearance index was calculated based on urea nitrogen level at 0, 48, and 96 h after CVVH treatment in 2 groups, platelet count (PLT), prothrombin time (PT), and activated partial thromboplastin time (APTT) in total coagulation of patients were recorded. The frequency of forced hemofiltration termination caused by adverse reactions such as severe hypocalcemia, aggravated wound bleeding, and new bleeding on non-wound surface of patients was recorded within 96 h of CVVH treatment. The duration of daily CVVH use from the beginning to the end was recorded. Data were statistically analyzed with chi-square test, analysis of variance for repeated measurement, independent samples t test, and Bonferroni correction. Results: There were no significant differences in urea nitrogen level, creatinine level, and CRP value in serum of patients between 2 groups at 0 h after treatment (P>0.05). At 48 and 96 h after treatment, urea nitrogen level, creatinine level, and CRP value in serum of patients in citrate group were significantly lower than those in heparin group (t=3.366, -2.315, 2.942, -2.657, 2.011, -2.441, P<0.05), and urea clearance index of patients in citrate group was significantly higher than that in heparin group (t=1.017, 2.233, P<0.05). There were no statistically significant differences in PLT, PT, and APTT of patients between 2 groups at 0 h after treatment (P>0.05). At 48 and 96 h, PLT of patients in citrate group was significantly higher than that in heparin group (t=-3.417, -4.143, P<0.05 or P<0.01), PT of patients in citrate group was significantly shorter than that in heparin group (t=2.760, -3.655, P<0.01), APTT of patients in citrate group was significantly shorter than that in heparin group (t=3.719, 5.146, P<0.05 or P<0.01). Within 96 h of treatment, there was 1 case of hypocalcemia and 1 case of aggravated wound bleeding resulting in forced hemofiltration termination in citrate group, but there was no new bleeding on non-wound surface; in heparin group, there was no hypocalcemia, but 7 cases of aggravated wound bleeding and 2 cases of new bleeding on non-wound surface (both at the tracheotomy site) resulting in forced hemofiltration termination. The use time of blood purification filter of patients in citrate group was (11.7±4.8) h, obviously longer than (6.6±2.5) h in heparin group (t=3.310, P<0.01). Conclusions: The use of regional citrate anticoagulation in CVVH treatment of severe burn patients has the advantages including little effect on coagulation function and high safety, can effectively prolong the use time of filter and improve the therapeutic effect, but this conclusion still needs to be further verified in clinical application.

Assessing handwriting in preschool-aged children: Reliability and internal consistency of the “Just Write!” tool

ABSTRACT Researchers utilized a cross-sectional secondary analysis of data within an ongoing non-randomized controlled trial study design to establish the reliability and internal consistency of a novel handwriting assessment for preschoolers, the Just Write! (JW), written by the authors. Seventy-eight children from an area preschool participated in the study by completing the JW and the Beery-Buktenica Developmental Test of Visual Motor Integration (VMI). The results indicate the JW can be reliably scored by novice and experienced practitioners. The results also indicate that grasp is not correlated with writing ability, and point toward developmental implications with upper and lower case writing. In addition, the authors provide the JW as an appendix to aide interested practitioners and researchers.

The Effects of Flipped Learning Approaches in Anatomy Class

Pedagogical innovations applying flipped learning models are being applied in nursing education. The aim of this study was to verify the effects of the flipped learning approach in an anatomy class among undergraduate nursing students. This was a non-randomized controlled study. Of 154 nursing students enrolled in an anatomy class in South Korea, 79 were in the lecture-based group and 75 were in the flipped learning group. Data were collected using structured questionnaires. Problem solving ability and self-leadership improved significantly in the flipped learning group after the intervention but decreased in the lecture-based group. There was no difference in critical thinking between the flipped learning and control groups. The participants in the flipped learning group were more satisfied with the class than those in the lecture-based group. Flipped learning facilitates interactive activities that support the needs of advanced learners and provide more opportunities to develop problem-solving abilities and self-leadership.

Meta-Analysis of the Effectiveness and Safety of Intravenous Thrombolysis in Patients with Acute Cerebral Infarction.

In this paper, a meta-analysis of the effectiveness and safety of intravenous thrombolysis in patients with acute cerebral infarction was carried out, the original literature inclusion criteria and retrieval strategies were developed, and the collection deadline was about new oral anticoagulants and other methods for the antithrombotic intravenous thrombolytic treatment of patients with acute cerebral infarction for the relevant literature on the safety and effectiveness comparison. First, the quality of the literature is evaluated according to whether the included studies are randomized controlled trials, whether there is randomized concealment, whether blinding is used, and whether they are withdrawn or lost to follow-up, and the RevMan 5.2 software is used for meta-analysis. At the same time, grey literature databases such as dissertations were experimentally searched, and all randomized controlled studies (RCT), nonrandomized controlled studies, case-controlled studies, cohort studies, case series reports, etc. of Wingspan in the treatment of intracranial atherosclerotic stenosis were collected. In the prevention of myocardial infarction in patients with acute cerebral infarction, the difference between the two was not statistically significant (RR = 0.82, 95% CI (0.57, 1.17), P = 0.27). Compared with other methods, it can significantly reduce the all-cause mortality of patients with nonvalvular venous thrombolysis, and the difference is statistically significant (RR = 0.90, 95% CI (0.85, 0.96), P = 0.001). Experimental results show that in terms of safety, the new oral anticoagulant is better than other methods in reducing minor bleeding in patients with acute cerebral infarction, and the difference is statistically significant (RR = 0.87, 95% CI (0.76, 0 99), P = 0.03); the effect is better than other methods in reducing the incidence of serious bleeding events, and the difference is statistically significant (RR = 0.79, 95% CI (0.74, 0.85), P < 0.00001).

Single-Port versus Multiple-Port Robot-Assisted Radical Prostatectomy: A Systematic Review and Meta-Analysis

Background: Single-port robotic-assisted radical prostatectomy has been reported as a safe and feasible technique. However, recent studies comparing single-port versus multiple-port robotic radical prostatectomy have displayed conflicting results. Objectives: To investigate the benefit of single-port robotic radical prostatectomy and the impact on outcome compared to multiple-port robotic radical prostatectomy. Methods: Based on PRISMA and AMSTAR criteria, a systematic review and meta-analysis were carried out. Finally, we considered the controlled studies with two cohorts (one cohort for single-port RARP and the other cohort for multiple-port RARP). For statistical analysis, Review Manager (RevMan) software version 5.4 was used. The Newcastle-Ottawa Scale was employed to assess the risk of bias. Results: Five non-randomized controlled studies with 666 patients were included. Single-port robotic radical prostatectomy was associated with shorter hospital stays. Only 60.6% of single-port patients (109/180) required analgesia compared to 90% (224/249) of multiple-port patients (Z = 3.50; p = 0.0005; 95% CI 0.07:0.47). Opioid administration was also significantly lower in single-port patients, 26.2% (34/130) vs. 56.6% (77/136) (Z = 4.90; p < 0.00001; 95% CI 0.15:–0.44) There was no significant difference in operative time, blood loss, complication rate, positive surgical margin rate, or continence at day 90. Conclusion: The available data on single-port robotic radical prostatectomy is very limited. However, it seems comparable to the multiple-port platform in terms of short-term outcomes when performed with expert surgeons. Single-port prostatectomies might provide a shorter hospital stay and a lower requirement for opioids; however, randomized trials with long-term follow-up are mandatory for valid comparisons.

Meta-Analysis Comparing Safety and Efficacy of Left Bundle Branch Area Pacing Versus His Bundle Pacing

Although His bundle pacing (HBP) can provide a physiologic ventricular activation pattern, it has disadvantages such as the difficulty of lead implantation, reduced R wave amplitudes, and high and unstable pacing thresholds. Recent studies have demonstrated that left bundle branch area pacing (LBBaP) might overcome these deficiencies. A total of 7 nonrandomized controlled studies including 786 patients (n=442 receiving LBBaP and n=344 receiving HBP) with bradyarrhythmia were evaluated. Compared with HBP, LBBaP appeared to result in increased R wave amplitudes (at implant: MD 9.84mV, 95% confidence interval [CI] 7.61 to 12.06 mV; at follow-up: MD 7.62mV, 95% CI 6.73 to 8.50 mV), lowered capture thresholds (at implant: MD -0.73V, 95% CI -0.81 to -0.64 V; at follow-up: MD -0.71V, 95% CI -0.92 to -0.50 V), shortened procedure times (MD -16.70minutes, 95% CI -26.51 to -6.90 minutes) and fluoroscopic durations (MD -6.16min, 95% CI -8.28 to -4.03 minutes), and increased success rates (odds ratio 2.14, 95% CI 1.23 to 3.74); all of these differences were significant. However, paced QRS durations, the lead impedance at implantation and follow-up, and incidence of lead-related complications such as lead dislodgement did not significantly differ between LBBaP and HBP. In conclusion, current evidence suggests that LBBaP is a potential alternative to HBP as a pacing modality with which to maintain an ideal physiologic pattern of ventricular activation through native His-Purkinje system stimulation.

Key components of person‐centered care for people with dementia: A systematic review of interventions to design a patient preference study

AbstractBackgroundTo provide Person‐Centered Care (PCC) for People with Dementia (PwD), patient’s stated preferences must be known. Data about stated care‐preferences among PwD are limited. This study aimed to identify key components of PCC for PwD by a systematic review of PCC‐interventions, to inform the construction of a decision model for PwD‐preference elicitation.MethodA protocol was registered with PROSPERO (CRD42021225084). A search of the concepts Dementia, Person‐Centered Care, and Intervention was performed in PubMed, EMBASE, and Web of Science in Nov2020. Study selection was based on 2‐stage screening against eligibility criteria, limited to randomized controlled trials (RCT) and nonrandomized controlled study (NRS) designs. Risk of bias was assessed with version 2 of the Cochrane risk‐of‐bias tool for randomized trials (RoB2) and the Newcastle‐Ottawa Scale (NOS) for nonrandomized studies. Information about authors, interventions, and outcomes were extracted and entered into an “Effects Table”. The identified PCC‐interventions were thus synthesized into intervention categories to form key components of PCC.ResultSearches identified 1781 records. 19 studies (15 RCT, 4 NRS) were included after screening. The quality of the studies varied between low to moderate. The individual interventions covered a wide range of non‐pharmacological, psychosocial offers, oftentimes bundled in multi‐component intervention‐sets. Nine intervention categories, i.e. key components of PCC to inform the construction of a decision model for PwD‐preference elicitation, emerged from data synthesis: sensory enhancement/relaxation, social contact, cognitive training, validation and reminiscence, physical activities, environmental adjustments, caregiver training and support, care organization and daily living assistance. Effect measures included i.a. agitation, quality of life, antipsychotic use, depression, neuropsychiatric symptoms and behavior, with mixed results concerning the effect of the PCC interventions. All studies were conducted in nursery home or hospital settings.ConclusionNine intervention categories as key components of PCC to inform the construction of a decision model for PwD‐preference elicitation could be identified. As the findings were limited to nursery home and hospital settings, community‐dwelling PwD and the primary care‐setting should find greater consideration for future investigations on PCC interventions and patient preference studies.

Spirituality in a Doctor's Practice: What Are the Issues?

Introduction: It is becoming increasingly important to address the spiritual dimension in the integral care of the people in order to adequately assist them in the processes of their illness and healing. Considering the spiritual dimension has an ethical basis because it attends to the values and spiritual needs of the person in clinical decision-making, as well as helping them cope with their illness. Doctors, although sensitive to this fact, approach spiritual care in clinical practice with little rigour due to certain facts, factors, and boundaries that are assessed in this review. Objective: To find out how doctors approach the spiritual dimension, describing its characteristics, the factors that influence it, and the limitations they encounter. Methodology: We conducted a review of the scientific literature to date in the PubMed, Scopus, and CINAHL databases of randomised and non-randomised controlled trials, observational studies, and qualitative studies written in Spanish, English, and Portuguese on the spiritual approach adopted by doctors in clinical practice. This review consisted of several phases: (i) the exclusion of duplicate records; (ii) the reading of titles and abstracts; (iii) the assessment of full articles and their methodological quality using the guidelines of the international Equator Network. Results: A total of 1414 publications were identified in the search, 373 of which were excluded for being off-topic or repeated in databases. Of the remaining 1041, 962 were excluded because they did not meet the inclusion criteria. After initial screening, 79 articles were selected, from which 17 were collected after reading the full text. A total of 8 studies were eligible for inclusion. There were three qualitative studies and five cross-sectional observational studies with sufficient methodological quality. The results showed the perspectives and principal characteristics identified by doctors in their approach to the spiritual dimension, with lack of training, a lack of time, and fear in addressing this dimension in the clinic the main findings. Conclusions: Although more and more scientific research is demonstrating the benefits of spiritual care in clinical practice and physicians are aware of it, efforts are needed to achieve true holistic care in which specific training in spiritual care plays a key role.

Self-directed Technology-Based Therapeutic Methods for Adult Patients Receiving Mental Health Services: Systematic Review.

BackgroundTechnological interventions used to treat illnesses and promote health are grouped under the umbrella term of digital therapeutics. The use of digital therapeutics is becoming increasingly common in mental health. Although many technologies are currently being implemented, research supporting their usability, efficacy, and risk requires further examination, especially for those interventions that can be used without support.ObjectiveThis review aims to identify the evidence-based, self-directed, technology-based methods of care that can be used in adult patients after they are discharged from mental health services. The interventions reviewed are automated with no human input required (either at the patient’s or at the technology’s end), so the patients can implement them without any support.MethodsA systematic review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) guidelines in 3 databases: PubMed, Web of Science, and OVID. The inclusion criteria were self-directed, automated, and technology-based interventions related to mental health, primarily for adults, having a solid evaluation process. The interventions had to be self-directed, in that the participants could use the technology without any external guidance.ResultsWe identified 36 papers that met the inclusion criteria: 26 randomized controlled trials, 9 nonrandomized controlled trial quantitative studies, and 1 qualitative study. The technologies used included websites, automated text messaging, phone apps, videos, computer software, and integrated voice response. There were 22 studies focused on internet-based cognitive behavioral therapies as a therapeutic paradigm compared with the waitlist, web-based human-delivered therapy, and other interventions. Among these studies, 14 used paradigms other than the internet-based cognitive behavioral therapy. Of the 8 studies comparing guided and unguided digital care, 3 showed no differences, 3 favored guided interventions, and 2 favored unguided interventions. The research also showed that dropout rates were as high as 80%, citing potential problems with the acceptability of the suggested technologies.ConclusionsThere is limited research on the efficacy and suitability of self-directed technology-based care options for mental health. Digital technologies have the potential to bridge the gap between ambulatory care and independent living. However, these interventions may need to be developed collaboratively with the users to encourage their acceptability and to avoid high dropout rates.

Diazoxide for the Treatment of Transitional Neonatal Hypoglycemia: A Systematic Review

Background: Neonatal hypoglycemia is widely recognized as a common, preventable cause of brain injury in infants. Early use of diazoxide, which attenuates insulin secretion, is a possible treatment strategy for neonates that fail first-line management of hypoglycemia. Objective: To systematically evaluate the effectiveness and safety of diazoxide compared to placebo or no diazoxide treatment for improving short- and long-term outcomes in neonates born at ≥35 weeks’ gestation who require treatment for transitional hypoglycemia. Methods: MEDLINE, SCOPUS, EMBASE, and Cochrane databases were searched from inception until November 2020. We included all published randomized and nonrandomized controlled studies of diazoxide therapy in neonates that reported 1 or more prespecified outcomes. We excluded studies that primarily reported on neonates born at &lt;35 weeks, with congenital hyperinsulinism or inborn errors of metabolism, or who started treatment after 1 month of age. Two authors independently performed screening, risk of bias assessment, data extraction, and rating of evidence certainty (GRADE). Meta-analysis was performed in RevMan (inverse variance, fixed effects). Results: A total of 161 studies were screened, 7 reviewed in full, and 1 included (N = 30). Low-certainty evidence suggested that diazoxide, compared with placebo, is associated with a shorter duration of intravenous fluids (mean difference [MD] –50 h, 95% confidence interval [CI] −94, −6), decreased time to achieve full enteral feeding (MD –49 h, 95% CI −91, −7), and euglycemia (MD –33 h, 95% CI −66, −0). Conclusions: Diazoxide may promote metabolic transition in late preterm and term neonates with transitional hypoglycemia. Further high-quality randomized trials are needed to assess short- and long-term effects of diazoxide therapy.

Abstract 12055: Immediate Effect of Yoga Based Om-Meditation on Heart Rate Variability During Different Phases of Menstruation

Introduction: Stress may play a role in causing menstrual irregularities predisposing to increased risk for cardiovascular disease (CVD). Stress and cyclic variations in endogenous hormone levels during the menstrual cycle (MC) may affect heart rate variability (HRV), a measure of cardiac autonomic function (CAF) and mental stress. Strategies that reduce stress and improve HRV may prevent menstrual irregularities and thus CVD. We evaluated the effect of yoga-based OM-meditation on HRV during different phases of MC in young healthy females. Methods: A non-randomized controlled study was conducted on healthy young females (n=20) with normal menstrual cycle. Meditation group subjects (n=10) practiced Om-meditation while control group subjects (n=10) relaxed quietly for 10 minutes. Each subject received an intervention thrice during menstrual, proliferative and secretory phase. Data was collected before and immediately after every intervention. BMI, blood pressure (BP), heart rate (HR) and HRV were measured. Frequency domain method was used for an analysis of HRV. Results: The mean age of participants was 19.2±0.79 and 19.3±0.82 years; and mean period of MC was 31.1±2.76 and 30.3±2.4 days in meditation and control group respectively. There was no change in the baseline values of BMI, BP and HR between two groups and were within normal range. Between group analysis (ANCOVA) of HRV spectrum showed that Om-meditation had significantly decreased low frequency (LF) component of HRV (p&lt;0.05) and LF/HF ratio (p&lt;0.05); and increased high frequency (HF) component (p&lt;0.05) of HRV during all the three phases of MC. Conclusion: These results suggest that practice of Om-meditation for 10 minutes can induce beneficial changes in HRV by reducing sympathetic activity and shifting autonomic balance towards parasympathetic dominance. Om-meditation may reduce mental stress and optimize CAF during different phases of MC. However, this needs an evaluation in a larger trial.

Effectiveness and Safety of Botulinum Toxin Type A in Treatment of Restless Legs Syndrome: A Systematic Review and Meta-Analysis.

Our study aimed to investigate the effectiveness and safety of botulinum toxin type A in patients with restless legs syndrome. We searched electronic databases, including PubMed, Cochrane Library, and Web of Science, up to 12 June 2021, for published articles. We enrolled randomized controlled clinical trials and non-randomized controlled studies involving patients with restless legs syndrome who were treated with botulinum toxin. Quality assessment was performed using the Cochrane risk of bias tool and Joanna Briggs Institute Critical Appraisal Checklist for Quasi-Experimental Studies. As for the results, we included four articles comprising 62 participants, two studies were randomized controlled trials. Improvement in International Restless Legs Syndrome Study Group (IRLSSG) rating scale was observed in three studies. Adverse events were temporary and self-limited. Meta-analyses were performed, including the two randomized controlled trials with 27 participants. Compared with placebo, botulinum toxin injection significantly reduced scores of IRLSSG rating scale (SMD, −0.819, 95% confidence interval [CI], −1.377 to −0.262). A total of 11.8% (95% CI, 0.7–72.4%) of patients reported at least one adverse event. In conclusion, botulinum toxin injection may relieve restless legs syndrome related symptoms. However, decisive conclusions cannot be drawn because of the small number of patients included in our meta-analysis. Large-scale, randomized controlled trials are warranted to discover the optimal dose, safety, and long-term effect of intervention with botulinum toxin type A for patients with restless legs syndrome.

Platelet Transfusions Prior to Lumbar Punctures, What Is the Evidence?

Introduction:Lumbar punctures (LPs) are routinely used to administer intrathecal chemotherapy for children and adults with hematologic malignancies. The platelet threshold at which an LP can be safely performed is a debated topic. A platelet count of ≥50x10 9/L is a widely accepted threshold despite sparse evidence supporting this number (Kaufman et al 2003). Previous studies failed to report any increase in the incidence of post-procedure adverse events in patients with a platelet count below this threshold who undergo LPs (Corroa et al 2018, Chung et al 2020, Öztürk et al 2021). However, these prior studies were limited in their sample size for the number of LPs done in patients with platelets <50 x 10 9/L.Objectives:To assess the effects of differing platelet transfusion thresholds (<50 x 10 9/L versus ≥50x10 9/L) in patients undergoing lumbar punctures.Methods:We performed a computerized search of Medline, Cochrane and Google Scholar databases through January 2021 for studies evaluating lumbar punctures in adult and pediatric patients. We searched for randomized control trials, non-randomized controlled trials, cohort studies, and retrospective case series. We included any study that involved transfusions of platelet concentrates and was given to prevent bleeding in people of any age with thrombocytopenia that required insertion of a lumbar puncture needle or epidural catheter. We screened 10502 studies and 17 of the studies met criteria for review and were included in the final review. Standard methodological review was completed for each study. Two review authors independently assessed studies for eligibility and extracted data. Results are expressed narratively, and a meta-analysis was performed evaluating traumatic taps with a platelet threshold of <50 x10 9/Lcompared to those over the transfusion threshold of ≥50x10 9/L.Results:We identified 7 retrospective cohort studies and 10 case series that contained patients who received and did not receive any platelets prior to lumbar puncture procedures (Table 1). Most of the studies (12/17) had a patient population that included an oncologic diagnosis with hematologic malignancies being the most common (Table 1). We summarized the studies in narrative form with relevant outcomes (Table 1).Spinal hematoma as an outcome was documented in 12/17 studies. There was no difference in spinal hematomas in patients with platelet counts of <50 x10 9/Lcompared to those over the transfusion threshold of ≥50x10 9/L (Table 1).We performed a meta-analysis in patients with platelet counts of <50 x10 9/Lcompared to those over the transfusion threshold of ≥50x10 9/L for the outcome of traumatic taps. When traumatic taps were defined as greater than 10 x 10 6 RBCs/L, the incidence of traumatic taps favored the patients who had a platelet count ≥50x10 9/L (Figure 1). However, when traumatic taps were defined as >400 RBCs/L the incidence of traumatic taps favored the patients who had a platelet count <50 x10 9/L (Figure 1).There were no studies that evaluated all-cause mortality within 30 days of the procedure, length of stay, and quality of life outcomes in patients.Conclusion:We found no clinical trials to base our recommendations on platelet thresholds prior to a lumbar puncture. We did find multiple studies that should have enough patients to determine if a platelet threshold less than <50 x10 9/L is associated with increased spinal hematomas. There was no increase in spinal hematomas when the platelet count <50 x10 9/L was compared to a cohort with a platelet count ≥50x10 9/L.The meta-analysis of traumatic taps depended on the definition of traumatic taps and when traumatic taps were defined as greater than 10 x 10 6 RBCs/L, the incidence of traumatic taps favored the patients who had a platelet count ≥50x10 9/L. Whereas, when traumatic taps were defined as >400 RBCs/L the incidence of traumatic taps favored the patients who had a platelet count <50 x10 9/L.A multicenter prospective study is needed to clarify the incidence of traumatic taps and to verify the data regarding spinal hematomas, other adverse events or quality of life measures in patients. [Display omitted] DisclosuresLaber: Alexion: Membership on an entity's Board of Directors or advisory committees. Visweshwar: Biogen Idec: Membership on an entity's Board of Directors or advisory committees. Jaglal: Novartis: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees.

Very Distal Femoral Periprosthetic Fractures: Replacement Versus Fixation: A Systematic Review.

To synthesize all-cause reoperations and complications data as well as secondary clinical and functional outcomes, after the management of very distal femur periprosthetic fractures (vDFPFs) in a geriatric patient population with either a distal femoral locking plate (DFLP) or distal femoral replacement (DFR). MEDLINE, Embase, and Web of Science were searched for English language articles from inception to March 16, 2020, in accordance to the PRISMA guidelines. Studies reporting the management of vDFPFs in adults older than 65 years with either a DFLP or DFR were included. To ensure this review solely focused on very distal femoral periprosthetic fractures, only fractures of the following classifications were included: (1) Lewis and Rorabeck type II or III, (2) Su and Associates' Classification of Supracondylar Fractures of the Distal Femur type III, (3) Backstein et al type F2, and/or (4) Kim et al type II or III. Three reviewers independently extracted data from the included studies. Study validity was assessed using the methodological index for nonrandomized studies (MINORS), a quality assessment tool for nonrandomized controlled studies in surgery. Twenty-five studies with 649 vDFPFs were included for analysis. There were 440 knees in the DFLP group (mean age range: 65.9-88.3 years) and 209 knees in the DFR group (mean age range: 71.0-84.8 years). Because of the literature's heterogeneity, the data were qualitatively synthesized. vDFPFs in the elderly treated with DFR underwent fewer reoperations relative to DFLP (0%-45% vs. 0%-77%, respectively). Time to weight-bearing was observably shorter in DFR studies relative to DFLP studies. Functional outcomes and postoperative range of motion indicated a trend for DFLP knees to outperform DFR knees. Future research should include prospective studies and cost-effectiveness evaluations to better understand the utility of DFR for these fractures. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The clinical utility of a written point-of-care Concussion Action Plan (CAP) in facilitating recovery from a concussive injury, and improve outcomes following emergency department discharge

Background: The majority of concussion injuries in children and adolescents are sports and/or recreational-related. Most have a typical clinical trajectory, making a full recovery by 3 weeks. This process however can be long and drawn-out as many practitioners are reluctant to move too quickly due to a lack of guidance. Post-concussion, many injured patients are robust enough to commence escalation of their activity earlier than is current suggested, with excessive rest often prolonging recovery. A tool that outlines a consistent and clear plan of action or CAP for patients recovering from a concussion has the potential to improve outcomes, increase parental satisfaction and may even reduce the burden of unscheduled visits to medical service providers such as General Practitioners or Emergency Departments. Method: A non-randomised controlled study was conducted in the emergency department of a single tertiary paediatric trauma centre over a 3-month period. Children aged 12-16 years presenting with a simple concussion (no hospitalisation or co-morbidity) were eligible to participate. On discharge from the emergency department, families were given, in addition to an education leaflet, a CAP with instruction on its use at home. CAP is a colour coded activity progression plan, with compatible cognitive and physical activities prescribed at each sequential stage. CAP includes a daily symptom diary to be recorded by the parent and/or caregiver to assist progression through the plan, in addition to having a record of symptom recovery should they need to visit their GP for advice. All participants were followed until full recovery. Outcomes of interest were; patient compliance, adverse events and unscheduled representations, with parental and/or caregiver satisfaction a secondary outcome. Results: During the study, 132 patients with a simple concussion were evaluated in the emergency department. Of these, 69 participated in the study, and the remaining 63 managed with education alone. The mean age was 12.8 years, 70% male, with recreation-related falls accounting for 68%. Non-compliance with instruction was reported in 4.3% of participants using CAP and 48% undergoing education. Deviation from CAP was reported in 3.4% of participants who made a rapid recovery. In all cases, parents were satisfied with CAP. Dissatisfaction was reported in 38% of those having education alone due to confusing or mis-information. No adverse outcomes were reported in either group. Unscheduled visits were reported in 11% of those undergoing education alone as the parent and/or caregiver was often unclear on how to progress a child toward normal activity. Discussion: The use of CAP improves outcome and streamlines the discharge process in a busy acute-care setting. Parents also need to understand the disease and what to do if expectations are not met. Education before discharge tailored to meet this need in addition to CAP is important. Conflict of interest statement: My co-authors and I acknowledge that we have no conflicts of interest of relevance to the submission of this abstract.

TP7.2.10 The Un-abating Debate of using Drains following Colorectal Anastomosis: a systematic review

Abstract Aims To study whether routine use of drains in colorectal surgery/anastomosis help reduce postoperative complications and whether has a selective role in high risk patients. Methods A systematic search of electronic database performed using PubMed, Embase, and Cochrane Central database. Clinical literature from 1988 to 2018 was reviewed including randomized, non-randomized controlled studies, meta-analysis and systematic reviews for routine use of drain versus no usage of drain at index surgery &amp; compared for clinical benefits. Terms used for search were ‘colorectal’, ‘rectal’, ‘colonic’ surgery/anastomosis’ and drain. Main outcome: anastomotic leak whilst secondary outcome were to study collections, re-surgical intervention, wound infection, DVT/PE, chest complications &amp; mortality. Case reports and small cohort studies (&amp;lt;25 patients) were excluded. Results 2243 patients were included from 14 RCTs, 2 meta-analysis and 3 systematic reviews. 1178 patients in the drain group and 1065 patients in the no drain group. Using Chi square test, data analysis demonstrated no statistically significant differences between the two groups (drains Versus no drains) for anastomotic leakage, P &amp;gt;0.35; re-operation, P &amp;gt;0.41, wound infection, P &amp;gt;0.41; DVT/PE, P &amp;gt; 1.1; chest complications, P &amp;gt; 0.51 and mortality, P &amp;gt;0.48. Conclusions Routine use of drains in colorectal surgery/anastomosis does not confer significant benefit in reducing postoperative complications. However, selective use of drains in the high risk patients for anastomotic leak may have a role but warrants more studies.

Інструментальна імпедансометрія як складова загально-клінічного обстеження задля визначення складу тіла у хворих на неінфекційні захворювання

The purpose of the study is to assess the clinical feasibility and indicators of instrumental impedance measurement in patients who are at various stages of the cardiovascular continuum, in order to increase the effectiveness of measures for the prevention and treatment of non-communicable diseases in Ukraine by improving the diagnosis and prevention of non-communicable diseases through the introduction of modern science-intensive technologies into medical practice. Materials and methods. An open, non-randomized controlled study was performed with the assessment of examination on a BF 500 body composition monitor (model HBF-500-E, Omron Healthcare, Japan) in 186 functionally healthy individuals (control; in 75 respondents of professional athletes (group K1), in 111 respondents – intern doctors (group K2)) and in 253 patients with non-communicable diseases (main group). The patients were divided into four subgroups (Pg1, Pg2, Pg3, Pg4) depending on the stage of the cardiovascular continuum. Results and discussion. Non-compliance with the norm of body composition was found in 83% of respondents in group K2 and in 100% of patients. 83% of people were deficient in muscle, 23% had preobesity, 6% were obese, and 5% had visceral obesity. Overweight by body mass index was in 30% of Pg1 patients, in 31% of Pg2 patients, in 30% of Pg3 patients, in 37% of Pg4 patients and obesity was in 32% of Pg1 patients, in 31% of Pg2 patients, in 25% of Pg3 patients, in 35% of Pg4 patients. Overweight in the percentage of fat was diagnosed in 17% of Pg1 patients, in 31% of Pg2 patients, in 21% of Pg3 patients, in 37% of Pg4 patients; obesity was in 37% of Pg1 patients, in 48% of Pg2 patients, in 56% of Pg3 patients, in 51% of Pg4 patients. Visceral obesity was diagnosed in 35% of Pg1 patients, in 56% of Pg2 patients, in 60% of Pg3 patients, in 77% of Pg4 patients. Deficiency of muscle percentage was found in 85% of Pg1 patients, in 91% of Pg2 patients, in 89% of Pg3 patients, and in 88% of Pg4 patients. Conclusion. Instrumental impedance measurement shows clinical significance and should become a mandatory method of Objective Structured Clinical Examination. The body composition of patients with non-communicable diseases is characterized by an increase in energy expenditure of the main metabolism, general and visceral obesity, muscle deficiency. The degree and number of cases of violation of body composition increases with the progression of the cardiovascular continuum

A web app based-music intervention (MUSIC-CARE) reduces sedative requirement and anxiety during coronary angioplasty

Coronary angiography is a procedure in which patients tend to present with a moderately high level of stress and anxiety. The present investigation sought to examine the impact of a patient controlled music listening intervention by mobile application (Music-Care) on sedative consumption as primary endpoint, and on pain, anxiety and satisfaction levels. This is a prospective non-randomized controlled clinical study. Patients scheduled to undergo coronary angioplasty under local anesthesia and sedation were recruited. A 76 patients were included, 54 were assigned under the music arm and 22 under the control arm. Medication intake during the procedure has been reported as well as anxiety as measured by numeric rating score and APAIS, pain and satisfaction scores. Music group was administered "U" sequence during the procedure. Patients under music took significantly less midazolam medication (median 1 vs 3 mg in control, p&lt;0.01). Additionally, there was a significant difference (p&lt;0.01) on anxiety (Mmusic = 2.9, Mcontrol = 4.2, p &lt;0.01) but not in pain score. Almost all of the patients from the music group (98%) were satisfied (score ≥ 4) vs 91% in control group. Music-Care program application provides a 2/3 reduction in midazolam sedation during coronary angiography under local anesthesia and sedation. Furthermore, cardiologists appreciated this technique and suggested it to assist with their procedure in ambulatory practice.

Role of enhanced recovery after surgery in total laparoscopic hysterectomy.

Introduction:Enhanced recovery after surgery (ERAS) principles is an evidence-based surgical management approach that requires cooperation across various medical specialties. In this study, we applied ERAS principles in total laparoscopic hysterectomy (TLH) and the post-operative outcomes like post-operative pain, nausea and vomiting, opioid requirement, day of discharge, and any other complaints were studied.Methods:The study was conducted in a private healthcare setup in Jodhpur, Rajasthan, India. In this non-randomised controlled study 103 patients who underwent TLH over a period of 1 year were alternatively allocated to the study group and the control group. There were 51 patients in the study group in whom ERAS principles were applied and 52 patients in control group in whom traditional post-operative care was given.Results:Post-operative nausea and vomiting and opioid requirement were significantly reduced in the study group (P < 0.05). The post-operative pain was similar in both groups. The majority of patients in study group were discharged within 24 h as compared to the routine discharge after 48 h.Conclusion:Following ERAS principles in TLH results in decrease in post-operative nausea and vomiting, post-operative opioid requirement and hospital stay. Hence, the ERAS principles should be the standard practice in TLH even in a developing country setup.