A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria: The Safe Testing of Risk for Asymptomatic Microhematuria Trial.

PURPOSE: AUA guidelines for patients with microhematuria (≥3 red blood cells [RBC]/high-power field [hpf]) include cystoscopy for most over age 40 due to risk of urothelial cancer (UC). Cxbladder Triage (CxbT) is a urinary genomic test with UC negative predictive value of 99%. In this prospective randomized controlled trial, we compared cystoscopy use in a standard of care (SOC) arm vs a marker-based approach. MATERIALS AND METHODS: All patients with hematuria provided urine for a CxbT. Those categorized as lower risk (LR), defined as 3 to 29 RBC/hpf and minimal smoking history (<10 pack-years) were randomized between the test group provided with the CxbT result vs the SOC control group. Negative CxbT patients were offered omission of cystoscopy with surveillance. "Not lower risk" (NLR) patients (>30 RBC/hpf or >10 pack-year smoking history) had a CxbT but otherwise SOC. Patient decision and outcomes were recorded. RESULTS: Of 390 eligible patients, 255 were NLR and 135 were LR randomized to CxbT informed decision or SOC. The median age was 62 years (range 18-94) and 54% were male. Overall, 63% of CxbT tests were negative. For NLR patients, 82% had cystoscopy. In the LR control group, cystoscopy was performed in 67% of SOC and 27% in the test group (relative risk 0.41 [95% CI 0.27-0.61]). Compared to cystoscopy, CxbT had 90% sensitivity, 56% specificity, and 99% negative predictive value for UC. CONCLUSIONS: In this prospective randomized controlled trial, use of CxbT in patients with LR hematuria resulted in 59% reduction of cystoscopy use. This clinical utility of CxbT can reduce the burden of unnecessary cystoscopies.

The Influence of Dietary Counseling Over 20 Years on Tracking of Non-High-Density Lipoprotein Cholesterol from Infancy to Young Adulthood.

This 26-year study found that non-high-density lipoprotein cholesterol (non-HDL-C) levels tracked from infancy to young adulthood suggesting early-life non-HDL-C could predict future levels. However, infancy-onset dietary counseling reduced the odds of maintaining at-risk non-HDL-C, highlighting the potential importance of early interventions in preventing cardiovascular risk associated with high pediatric non-HDL-C.

The Effect of the Art Therapy Interventions on Depression Symptoms Among Older Adults: A Meta-analysis of Controlled Clinical Trials.

BACKGROUND: To our knowledge, no systematic reviews and meta-analyses have yet been published that examine the effect of art therapy (AT) interventions on depression symptoms among older adults, and this study aimed to systematically review and meta-analysis of clinical trials, summarize eligible relevant studies and provide a true effect measure for the association between AT and depression symptoms in older adults. METHODS: The databases of PubMed, Web of Science, Scopus, and the Cochrane Central Register of Controlled Trials were searched until 15 February 2022. The methodological quality of the included studies was evaluated by the Delphi checklist. The heterogeneity across studies was conducted by chi-squared test and measured its quantity by the I2 statistic. We performed this meta-analysis to obtain a summary measure of the mean difference in depression scores between AT and control groups using a random-effects model. All statistical analyses were carried out at a significance level of .05 using Stata software, version 14. RESULTS: Until 15 February 2022, 222 studies through databases and 199 studies through review of references were included in the present meta-analysis. In total, the analysis covered 8 studies. The difference in mean depression score between the intervention and control groups showed significant reductions in the AT group (MD -.78; 95% CI: -1.17, -.38; I 2 = 67.9%). CONCLUSION: Our findings suggest that AT can be considered an effective intervention for reducing depression symptoms among older adults and art therapists/psychotherapists can use this method to reduce the symptoms of depression among older adults.

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials.

In clinical trials, harms (i.e., adverse events) are often reported by simply counting the number of people who experienced each event. Reporting only frequencies ignores other dimensions of the data that are important for stakeholders, including severity, seriousness, rate (recurrence), timing, and groups of related harms. Additionally, application of selection criteria to harms prevents most from being reported. Visualization of data could improve communication of multidimensional data. We replicated and compared the characteristics of 6 different approaches for visualizing harms: dot plot, stacked bar chart, volcano plot, heat map, treemap, and tendril plot. We considered binary events using individual participant data from a randomized trial of gabapentin for neuropathic pain. We assessed their value using a heuristic approach and a group of content experts. We produced all figures using R and share the open-source code on GitHub. Most original visualizations propose presenting individual harms (e.g., dizziness, somnolence) alone or alongside higher level (e.g., by body systems) summaries of harms, although they could be applied at either level. Visualizations can present different dimensions of all harms observed in trials. Except for the tendril plot, all other plots do not require individual participant data. The dot plot and volcano plot are favored as visualization approaches to present an overall summary of harms data. Our value assessment found the dot plot and volcano plot were favored by content experts. Using visualizations to report harms could improve communication. Trialists can use our provided code to easily implement these approaches.

Promoting urinary continence with nonpharmacological interventions in Parkinson's disease.

Background: The evidence of nonpharmacological interventions promoting urinary continence in Parkinson's disease is low and rehabilitation nurses do not give it a high priority. Aim: To examine the effects of a urinary incontinence management program on continence and quality of life in persons with Parkinson's disease in inpatient rehabilitation. The acceptance of the intervention and the knowledge of the nurses were also of interest. Methods: A nonrandomized experimental study was conducted. The data collection commenced with a control group followed by an intervention group. A structured urinary incontinence management was performed in the intervention phase. This includes incontinence assessment, care planning, individual interventions, discharge planning, and telephone support at home. Results: Urinary continence and quality of life were enhanced in both groups; however, improvements were higher in the intervention group but the differences were not significant. Knowledge of the nurses about urinary incontinence improved during the study duration. The acceptance of the intervention was high. Conclusions: A structured urinary continence management may improve urinary continence in persons suffering from Parkinson's disease. In clinical practice it is important to perform a detailed assessment to identify problems regarding urinary incontinence.

Clinical effects and safety of edaravone in treatment of acute ischaemic stroke: A meta-analysis of randomized controlled trials.

WHAT IS KNOWN AND OBJECTIVE: Edaravone is a new antioxidant and hydroxyl radical scavenger. Although there is evidence that it improves clinical outcomes of patients with acute ischaemic stroke (AIS), it is not yet widely accepted for treatment of AIS in Western countries. We further investigated the efficacy and safety of edaravone through this meta-analysis of randomized controlled clinical trials (RCTs). METHOD: Pubmed, Embase, Web of Science and Cochrane Library were screened up to December 2020 for original articles from SCI journals that published in English. RCTs that compared edaravone versus placebo or no intervention in adult patients and reported the efficacy or safety of edaravone were regarded as eligible. Mortality was regarded as the primary outcome and the improvement of neurological impairment was regarded as the secondary outcome. Safety evaluation was conducted according to the incidence of adverse events. Review Manager 5.3 was employed to perform the assessment of the risk of bias and data synthesis. The Cochrane risk of bias tool for randomized controlled trials was employed to assess the risk of bias. RESULTS AND DISCUSSION: Seven randomized controlled trials with 2069 patients were included. For the incidence of mortality, the pooled RR for studies that evaluated edaravone after three-month follow-up was 0.55 (95% Cl, 0.43-0.7, I2  = 0, P < 0.01). The pooled RR for improvement of neurological impairment at the three months follow-up was 1.54 (95% CI, 1.27-1.87, I2  = 0, P < 0.01) in four RCTs. On subgroup analysis of studies that were conducted in Asia, the RR was 1.56 (95% CI, 1.27-1.90, I2  = 0%; P < 0.01); the pooled RR for studies that conducted in Europe was 1.32 (95% CI, 0.64-2.72; P = 0.45); the pooled RR for studies that used edaravone for two weeks was 1.42 (95% CI, 1.10 to 1.83, I2  = 0%; P < 0.01); the pooled RR for studies that used edaravone for one week was 1.64 (95% CI, 1.24-2.16, I2  = 0%; P < 0.01); the pooled RR for studies that conducted in patients with mean age equal to or over 60 years was 1.52 (95% CI, 1.24-1.87, I2  = 0%; P < 0.01); and the pooled RR for studies that conducted in patients with mean age less than 60 was 1.80 (95% CI, 1.05-3.08, I2  = 0%; P = 0.03). For the incidence of any treatment-related adverse events, the pooled RR for studies that evaluated edaravone during treatment was 0.83 (95% CI, 0.51-1.34, I2  = 0, P = 0.43). The difference of the incidence of any treatment-related adverse events between two groups was not statistically significant. WHAT IS NEW AND CONCLUSION: The limited studies indicate that edaravone can improve neurological impairment with a survival benefit at three-month follow-up, regardless of the mean age and course of treatment. It is worthy of promotion in the clinical treatment of AIS in Asian countries. More well-designed RCTs with larger sample sizes are needed to determine the benefits of edaravone in patients from Western countries.

Effectiveness of photobiomodulation in the treatment of primary burning mouth syndrome-a systematic review and meta-analysis.

To evaluate the effectiveness of photobiomodulation (PBM) on primary burning mouth syndrome (pBMS). We searched Chinese and English studies published before February 10, 2020. The databases used include PubMed, EMBASE, the Cochrane Library, Web of Science, Wanfang Database, and China National Knowledge Infrastructure (CNKI). Randomized controlled clinical trials (RCTs) that used the PBM to treat pBMS and reported specific treatment outcomes were considered for inclusion. We eventually included 12 RCTs, and 574 samples were included in these studies. The primary outcomes investigated were pain reduction and life quality improvement. A meta-analysis performed on 9 groups in 5 trials showed that PBM was effective in reducing pain compared with placebo (MD - 1.86, 95% CI - 2.59 to - 1.13, Z = 4.99, P < 0.00001). Meta-analysis was also performed on 7 groups in 4 trials and showed that PBM was effective in improving life quality compared with placebo (MD - 3.43, 95% CI - 5.11 to - 1.75, Z = 4.00, P < 0.0001). Qualitative analysis of the included RCTs found that PBM might also play a role in the decrease of TNF-α and IL-6 in saliva. Three studies that compared PBM with medications were evaluated by descriptive analysis. None of the treatment-related adverse event was reported. Up to date, PBM appears to have an effect on pain reduction and life quality improvement in pBMS patients. However, more evidence is still required to warrant its efficacy and safety in treating pBMS.

The comparison of albumin and 6% hydroxyethyl starches (130/0.4) in cardiac surgery: a meta-analysis of randomized controlled clinical trials.

BACKGROUND: Fluid administration is a key tool in the maintenance of normovolemia in patients with cardiac surgery. The trials that evaluated the safety of 6% hydroxyethyl starch (HES) 130/0.4 in cardiac surgical patients were inconsistent. It is necessary to compare the efficacy and safety of albumin and 6% HES (130/0.4). METHOD: We searched for the randomized controlled clinical trials that compared human albumin with 6% HES (130/0.4) in cardiac surgery in PubMed, Cochrane, and Embase. RESULTS: Ten studies involved a total of 1567 patients were included in our meta-analysis. For the efficiency, there was no difference in total volume of infusion between compared groups [P = 0.64, Fixed Effect Model (FEM): standardized mean difference (SMD) = 0.04, 95% confidence interval (CI) (- 0.12, 0.20)]. As for safety, the albumin show more risk than hydroxyethyl starch 130/0.4 in blood loss [P = 0.02, FEM: SMD: 0.22, 95% CI (0.03, 0.41)]. There was no difference in the frequency of transfusions (P = 0.20, RR = 1.11; 95% CI (0.95, 1.27)) between the two groups. No difference was observed for the days in intensive care unit [P = 0.05, FEM: SMD = - 0.18, 95% CI (- 0.36, 0.00)], and the days in hospital [P = 0.32, FEM: SMD = - 0.11, 95% CI (- 0.32, 0.10)]. Furthermore, both the incidence of AKI, RRT, and mortality were comparable in the two groups. CONCLUSION: This study provided evidence that the 6% HES (130/0.4) might be the substitute for HA, which reduced the economic burden for patients with cardiac surgery. However, the effect of 6% HES (130/0.4) and HA on AKI still needs to be further studied.

A randomized clinical trial of class II composite restorations using direct and semidirect techniques.

OBJECTIVE: This prospective study evaluated the clinical performance of large class II restorations made with different techniques over 24 months. MATERIALS AND METHODS: Thirty patients received two class II restorations (n = 60) using a nanohybrid composite and different restorative techniques (direct (DT), semidirect (SDT)), in a split-mouth randomized design. The same adhesive system was applied for all restorations. For DT, the restorative material was applied directly inside the tooth preparation. For SDT, a tooth preparation impression was obtained using alginate and a silicone flexible die was prepared. The restoration was made chairside on the model and additionally light cured. After that, it was cemented in preparation using resinous cement. All restorations were evaluated using the FDI criteria after 7 days, 6, 12, and 24 months postoperatively. RESULTS: After 24 months, 24 patients attended the recall and 48 restorations were evaluated. Fisher's statistical analysis (5%) showed no difference between the techniques. Nevertheless, Friedman's test showed significant differences for some criteria after 12 months of evaluation for both techniques. Postoperative sensitivity was reported in one DT restoration. Also, after 24 months, one SDT restoration presented marginal fracture, which was deemed unsatisfactory. CONCLUSIONS: After a 24-month follow-up, no significant difference between the tested techniques was detected. The restorations performed with both techniques produced clinically acceptable restorations. CLINICAL RELEVANCE: This study demonstrated the viability of applying two different operatory techniques (direct and semidirect) for class II resin composite restorations.

Patient-Administered Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Control After Laparoscopic Cholecystectomy: A Randomized, Sham-Controlled Feasibility Trial.

OBJECTIVES: Transcutaneous electrical nerve stimulation (TENS) is a noninvasive analgesic neurostimulation modality. Difficulties in clinical trial blinding and therapy administration have limited conclusions of previous trials. The aims of this study were to first investigate the feasibility and acceptability of patient-administered TENS after surgery, and second, the feasibility of using sub-sensory TENS as a proxy sham group for patient-blinding. MATERIALS AND METHODS: Over a four-month period, patients undergoing laparoscopic cholecystectomy at a single center were randomized to receive maximally tolerable high-intensity (HI) TENS or sub-sensory low-intensity (LI) TENS. Patients and outcome assessors were blinded. Primary outcomes were the feasibility, tolerability, and acceptability of patient self-administered TENS, measured by patient-reported outcomes, and the strength of patient-blinding, measured using the James Blinding Index (JBI). Secondary outcomes explored clinical recovery and analgesic efficacy. RESULTS: Nineteen patients were screened for inclusion; ten patients were randomized and completed the feasibility study. TENS therapy was variably utilized (median duration of TENS 5.3 hours/day [IQR: 4.1-6.9]). The JBI was 0.7, indicating a strong strength of blinding. Majority of patients found the TENS unit easy to use (90%) and were confident with self-administration (100%). No patients experienced adverse effects of TENS use. CONCLUSIONS: Patient-administered TENS is safe and acceptable. Future studies may use sub-sensory TENS as a proxy sham control to more reliably blind patients. A larger, double-blinded RCT employing these techniques is now needed to determine the analgesic efficacy of TENS in an enhanced recovery setting, and its potential to reduce opiate usage.

Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

Anterior versus posterior instrumentation for treatment of thoracolumbar tuberculosis : A meta-analysis.

BACKGROUND: To compare clinical and functional outcomes of anterior versus posterior debridement and spinal fixation for surgical treatment of thoracolumbar tuberculosis. METHODS: A computer-based online search of the Cochrane Library, PubMed, EMBase, Wanfang, VIP, and the CNKI database was performed. The methodological quality of included studies was evaluated, and data analyses were performed using RevMan 5.0 software (The Nordic Cochrane Centre, The Cochrane Collaboration Copenhagen, Denmark). RESULTS: Eleven trials were studied, with eight performed in China, two in Egypt, and one in India. The results showed significant differences between the two operative approaches in terms of correction of kyphotic angle and intraoperative blood loss, but not in terms of operation time, hospital stay, fusion time, and loss of correction at the final follow-up. CONCLUSION: The anterior and posterior approaches are equally good methods for treatment of thoracolumbar tuberculosis. The anterior approach results in less blood loss, whereas posterior instrumentation is better suited for correction of kyphotic angle.

Efficacies of Various Surgical Regimens in the Treatment of Renal Calculi Patients: a Network Meta-Analysis in 25 Enrolled Controlled Clinical Trials.

BACKGROUND/AIMS: Renal calculi, or kidney stones, are masses made of crystals that affect people of all geographical, cultural, and racial groups. We conduct this study with the aim of comparing the efficacy of various surgical methods in the treatment of renal calculi. METHODS: Controlled clinical trials (CCTs) related to different surgical treatment approaches for renal calculi were included in this study by retrieving them from electronic English databases. The odds ratios (OR), the weighted mean difference (WMD), 95% confidence intervals (95% CI) and surface under the cumulative ranking curves (SUCRA) were evaluated, followed by a cluster analysis. RESULTS: Compared with the extracorporeal shockwave lithotripsy (SWL), minimally invasive percutaneous nephrolithotomy (mini-PCNL), retrograde intrarenal surgery (RIRS), standard percutaneous nephrolithotomy (standard PCNL), ureterorenoscopy (URS) and micro-percutaneous nephrolithotomy (microperc) regimens, the open anatrophic nephrolithotomy (Open AN), URS + RIRS and laparoscopic pyelolithotomy (LP) surgical procedures all presented with a higher stone-free rate in renal calculi. Lower auxiliary procedures were found in the URS + RIRS treatment approach compared with SWL, RIRS, URS and microperc regimens. In addition, the SWL regimen indicated a lower stone-free rate than the mini-PCNL, standard PCNL, Open AN, URS + RIRS and LP regimens. Finally, the RIRS regimen presented with the shortest in-patient stay compared to the mini-PCNL, standard PCNL, Open AN, URS, URS + RIRS and LP regimens. CONCLUSION: This meta-analysis demonstrated that the URS + RIRS surgical procedure has the best stone-free rate and the lowest number of auxiliary procedures. The RIRS and Microperc both have the shortest hospital stay and operative time.

Access to clinical trials among oncology patients: results of a cross sectional survey.

BACKGROUND: Clinical trials are necessary for the advancement of cancer treatment and care, however low rates of participation in such trials limit the generalisability of findings. The objective of this study was to examine the proportion of medical oncology outpatients in Australia who are invited and consent to participate in clinical trials and the factors associated with this. METHODS: A sample of adult medical oncology patients was recruited from three Australian cancer treatment centres. Consenting patients completed two paper-and-pencil surveys; one at the time of consent and another approximately 1 month later. A multivariate logistic regression was conducted to explore factors associated with invitation and participation in a trial. RESULTS: Thirty-eight percent (n = 146) of the 383 participants reported they had been invited to take part in a clinical trial. Of those invited, 93% reported consenting to participate in the trial, with the majority indicating that they did not regret their decision (89%). Treatment centre and time since diagnosis were significantly associated with being invited to take part in a clinical trial. None of the factors examined were associated with clinical trial consent rates. CONCLUSIONS: The main barrier to clinical trial participation is not being invited to do so, with the centre the patient attends being a modifiable determinant of whether or not they are invited. Increasing the resources available to treatment centres to ensure all patients are offered participation in trials they are eligible for may help to improve rates of trial participation.

The emerging role of anamorelin hydrochloride in the management of patients with cancer anorexia-cachexia.

Cancer cachexia affects many patients with advanced cancer. This multifactorial syndrome, which involves loss of muscle mass and body weight, profoundly affects patients' physical functioning and quality of life. Pharmacologic interventions that target weight loss and also improve patient-reported measures are required. Anamorelin hydrochloride is an oral ghrelin receptor agonist for the treatment of cancer anorexia-cachexia that stimulates release of growth hormone and insulin-like growth factor 1, and improves food intake and body weight. Phase II and III trials have demonstrated that anamorelin increases body muscle and fat composition, and improves patient-reported appetite and quality of life. Anamorelin shows promise as an anabolic agent with benefits maintained over time, without the virilizing side effects of other anabolic medications.

Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System.

BACKGROUND: Deep brain stimulation (DBS) is the most commonly performed surgery for the debilitating symptoms of Parkinson disease (PD). However, DBS systems remain largely unaffordable to patients in developing countries, warranting the development of a safe, economically viable, and functionally comparable alternative. OBJECTIVE: To investigate the efficacy and safety of wirelessly programmed DBS of bilateral subthalamic nucleus (STN) in patients with primary PD. METHODS: Sixty-four patients with primary PD were randomly divided into test and control groups (1:1), where DBS was initiated at either 1 month or 3 months, respectively, after surgery. Safety and efficacy of the treatment were compared between on- and off-medication states 3 months after surgery. Outcome measures included analysis of Unified Parkinson's Disease Rating Scale (UPDRS) scores, duration of "on" periods, and daily equivalent doses of levodopa. All patients were followed up both 6 and 12 months after surgery. RESULTS: Three months after surgery, significant decrease in the UPDRS motor scores were observed for the test group in the off-medication state (25.08 ± 1.00) versus the control group (4.20 ± 1.99). CONCLUSIONS: Bilateral wireless programming STN-DBS is safe and effective for patients with primary PD in whom medical management has failed to restore motor function.

[Interventions for promoting physical activity in nursing homes : Systematic review of the effectiveness of universal prevention]. / Interventionen zur Förderung der körperlichen Aktivität in Pflegeheimen : Systematische Übersicht der Wirksamkeit universeller Prävention.

BACKGROUND: Among residents of nursing homes, physical activity might be beneficial in maintaining health-related quality of life because impairment is caused in particular by functional decline. The aim is the evaluation of the effectiveness of universal preventive interventions directed at increasing physical activity on activities of daily living in nursing home residents. MATERIAL AND METHODS: Relevant studies were identified through database searching in MEDLINE, the Cochrane library, EMBASE, CINAHL, PsycINFO and PEDro. Two review authors independently selected articles, assessed the risk of bias and extracted data. Results were combined in random effects meta-analyses. RESULTS: By including 14 primary studies, nursing home residents participating in physical activities showed a statistically significant greater physical functioning compared to controls (standardized mean difference [SMD] = 0.48, 95% confidence interval [95% CI] 0.26-0.71, p < 0.0001). Subgroup analyses suggest that especially nursing home residents with severe physical and cognitive impairment might benefit from participation in physical activities. Results after non-training periods substantiate the necessity of a sustained implementation. Due to the high risk of bias in included studies, the results must be interpreted with caution. CONCLUSION: Physical activity for nursing home residents can be effective. Considering the low-quality evidence, performance of high-quality studies is essential in order to verify the statistical results.

Efficacy and safety of blood transfusion in obstetric patients: systematic review of the literature.

OBJECTIVES: To evaluate the efficacy of blood transfusion compared to no intervention in obstetric patients. MATERIAL AND METHODS: A systematic review was performed with Cochrane Database of Clinical Trials, PubMed, EMBASE and LILACS databases searched as of September, 2016. Two authors independently selected relevant clinical trials, assessed their methodological quality and extracted data, using the GRADE approach. RESULTS: Five studies within a total of 6,297 met the inclusion criteria, with women generally aged 20-40 years. Three included studies allocated women to receive blood transfusion or no intervention. Two other studies allocated women with either restricted or full blood supplies. The major issue regarding risk of bias was the extent of concealment of randomization and blinding. There was no statistically significant difference between blood transfusion versus no transfusion or restricted blood supply on mortality (relative risk 0.82 [95% confidential interval 0.32 to 2.09], p = 0.68; two studies; I2 = not applicable). CONCLUSIONS: Very low-quality evidence suggests no significant difference between blood transfusion and no intervention in obstetric patients, underlining the need for more robust clinical trials evaluating this area.

Effects of low-dose morphine on perceived sleep quality in patients with refractory breathlessness: A hypothesis generating study.

BACKGROUND AND OBJECTIVE: The management of chronic refractory breathlessness is one of the indications for regular low-dose (≤30 mg/24 h) oral sustained release morphine. Morphine may disrupt sleep in some conditions and improve sleep quality in others. This study aimed to determine any signal of regular, low-dose morphine on perceived sleep disruption due to breathlessness and perceived sleep quality. METHODS: This is a secondary analysis of data from 38 participants with refractory breathlessness (30 male; 33 with COPD) aged 76 ± 0.9 years who completed a double-blind, randomized, placebo-controlled, cross-over study in which they received 20 mg oral sustained release morphine daily and placebo for 4 days each. Participant ratings of sleep disruption due to breathlessness and perceived sleep quality were obtained daily throughout the 8-day trial. RESULTS: Perceived sleep disruption due to breathlessness over the 4-day period ranged between 13% and 32% of participants for placebo and 13% and 26% for morphine, decreasing by each day of the study during the morphine arm. Most participants reported 'very good' or 'quite good' sleep throughout the trial and were less likely to perceive poor sleep quality during the morphine arm (odds ratio = 0.55, 95% confidence interval: 0.34-0.88, P = 0.01). Participants who reported decreased breathlessness during the 4 days on morphine were also likely to report improved sleep quality with morphine (P = 0.039). CONCLUSION: Four days of low-dose morphine improved perceived sleep quality in elderly participants with refractory breathlessness. Regular low-dose morphine targeted to reduce refractory breathlessness may yield associated benefits by reducing sleep disruption and improving sleep quality.

The effect of renal denervation on resistant hypertension: Meta-analysis of randomized controlled clinical trials.

BACKGROUND: This meta-analysis was conducted to evaluate the efficiency of renal denervation (RDN) on resistant hypertension. METHODS: PubMed, EMBASE, and the Cochrane Central database were searched for eligible randomized controlled clinical trials (RCTs). Changes from the baseline of the office blood pressure and the 24-h ambulatory blood pressure were extracted. RESULTS: Nine RCTs were included. RDN reduced the mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) by -8.23 mm Hg (95%CI: -16.86, 0.39) and -3.77 mm Hg (95%CI: -7.21, -0.32), respectively, compared with the control. In the population with a baseline SBP more than 170 mm Hg, the RDN reduced SBP by -17.77 mm Hg (95%CI: -33.73, -1.82) and DBP by -7.51 mm Hg (95%CI: -12.58, -2.44). In the subgroup with no medication adjustment, the RDN reduced SBP by -15.56 mm Hg (95%CI: -26.33, -4.80) and DBP by -6.89 mm Hg (95%CI: -9.99, -3.79). The proportion of patients with SBP decrease of 10 mm Hg or more and the controlled office BP were not different between two groups. RDN reduced 24-h mean SBP and DBP by -3.34 mm Hg (95%CI: -5.30, -1.38) and -1.56 mm Hg (95%CI: -2.71, -0.41), respectively. The SBPs in the subgroups with higher baseline SBP and with no medication adjustment were significantly decreased after the HTN-3 was omitted. CONCLUSION: Radiofrequency RDN in a randomized manner did not have superiority compared with medical treatment at 6-month follow-up in general population. Current evidence provides insufficient evidence to support the use of such RDN strategy in the treatment of resistant hypertension. The result could not be used to extrapolate other strategies' effect.