Prospective Randomized Control Trial Research Articles

Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV

BackgroundSignificant disparities continue to exist in the HIV care continuum, whereby Hispanic and Black people living with HIV (PLWH) are less likely to achieve viral suppression compared to their White counterparts. Studies have shown that intervention approaches that involve peer navigation may play an important role in supporting patients to stay engaged in HIV care. However, implementation may be challenging in real-world settings where there are limited resources to support peer navigators. Combining a peer navigation approach with scalable mobile health (mHealth) technology may improve impact and implementation outcomes.MethodsWe combined a peer navigation intervention with a mHealth application and are conducting a randomized controlled trial (RCT) to test the efficacy of this integrated “Peers plus mobile App for Treatment in HIV” (PATH) intervention to improve HIV care engagement, and ultimately sustained viral suppression, among Hispanic and Black PLWH. We will enroll up to 375 PLWH into a two-arm prospective RCT, conducting follow-up assessments every 3 months up to 12 months post-baseline. Participants randomized to the control arm will continue to receive usual care Ryan White Program case management services. Individuals randomized to receive the PATH intervention will receive usual care plus access to two main intervention components: (1) a peer navigation program and (2) a mHealth web application. The primary outcome is sustained HIV viral suppression (undetectable viral load observed at 6- and 12-month follow-up). Secondary outcomes are retention in HIV care, gaps in HIV medical visits, and self-reported ART adherence. Recruitment for the RCT began in November 2021 and will continue until June 2024. Follow-up assessments and medical chart abstractions will be conducted to collect measurements of outcome variables.DiscussionThe efficacy trial of PATH will help to fill gaps in our scientific understanding of how a combined peer navigation and mHealth approach may produce effects on HIV care outcomes while addressing potential implementation challenges of peer navigation in Ryan White-funded clinics.Trial registrationThe PATH trial is registered at the United States National Institutes of Health National Library of Medicine (ClinicalTrials.gov) under ID # NCT05427318. Registered on 22 June 2022.

Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial.

Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting. We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants' satisfaction with the consent discussion. We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen's d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen's effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen's effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants' self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149). The addition of digital education platform to standard verbal consent significantly improves patient's early and delayed understanding of risks and benefits of LC in an acute care setting.

Cost-utility analysis and impact on the environment of videoconference in pressure injury. A randomized controlled trial in individuals with spinal cord injury

Study designA prospective randomized controlled trial (RCT) in persons with spinal cord injury (SCI) and ongoing pressure injury (PI).ObjectivesThe main aim was to perform a cost-utility analysis (CUA) alongside the RCT comparing regular care to regular care with additional videoconference consultations. Secondary aims were to assess costs and greenhouse gas emission related to transportation in the two study groups.SettingTwo spinal cord units in Norway.MethodsParticipants were allocated to a regular care group (RCG) and a regular care group with additional videoconference (VCG), in a 1-year follow-up between 2016 and 2018. Costs were prospectively collected, and health-related quality of life (HRQoL) data were collected at baseline and 12 months. The outcome was quality-adjusted life years (QALYs), derived from the EQ-5D-5L questionnaire. Results are reported as incremental cost-effectiveness ratio (ICER), expressed as the cost per additional QALY gained. Transportation related costs and environmental emissions were compared by t-tests.ResultsThere were 56 participants included, 28 in each group. Of these 27 in the VCG and 26 in the RCG completed. Three participants died. The mean cost per patient was € 8819 in the VCG and € 3607 in the RCG, with 0.1 QALYs gained in the VCG. No significant differences were identified regarding HRQoL or secondary outcomes.ConclusionThe VCG costs € 5212 more for an additional 0.1 QALYs, giving an ICER of € 52,120 per QALY. No significant differences were found regarding transportation-related costs, or emission of greenhouse gases.Trial registrationwww.ClinicalTrials.gov; NCT02800915, TeleSCIpi. CRISTIN.no. https://app.cristin.no/projects/show.jsf?id=545284. Sunnaas Rehabilitation hospital’s web page, available at https://www.sunnaas.no/fag-og-forskning/fagstoff/sar.

The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies with Intrauterine Growth Restriction: A Prospective Randomized Control Trial

The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies with Intrauterine Growth Restriction: A Prospective Randomized Control Trial

Is Postoperative Splinting Advantageous After Upper Extremity Fracture Surgery? Results From the Arm Splint Pain Improvement Research Experiment.

The authors report no conflict of interest.To determine if short-term immobilization with a rigid long arm plaster elbow splint after surgery of the arm, elbow, or forearm results in superior outcomes compared with a soft dressing with early motion. Prospective Randomized Control Trial. Academic Medical Center. Patients undergoing operative treatment for a mid-diaphysis or distal humerus, elbow, or forearm fracture were consented and randomized according to the study protocol for postoperative application of a rigid elbow splint (10-14 days in a plaster Sugar Tong Splint for forearm fracture or a Long Arm plaster Splint for 10-14 for all others) or soft dressing and allowing immediate free range of elbow and wrist motion (range of motion [ROM]). Self-reported pain (visual analog score or VAS), Healthscale (0-100, 100 denoting excellent health), and physical function (EuroQol 5 Dimension or EQ-5D) surveyed on postoperative days 1-5 and 14 were compared between groups. Patient-reported pain score (0-10, 10 denoting highest satisfaction) at week 6, time to fracture union, ultimate disabilities of the arm, shoulder, and hand score, and elbow ROM were also collected for analysis. Incidence of complications were assessed. Hundred patients (38 men to 62 women with a mean age of 55.7 years) were included. Over the first 5 days and again at postop day 14, the splint cohort reported a higher "Healthscale" from 0 to 100 than the nonsplint group on all study days ( P = 0.041). There was no difference in reported pain between the 2 study groups over the same interval ( P = 0.161 and 0.338 for least and worst pain, respectively), and both groups reported similar rates of treatment satisfaction ( P = 0.30). Physical function ( P = 0.67) and rates of wound problems ( P = 0.27) were similar. Additionally, the mean time to fracture healing was similar for the splint and control groups (4.6 ± 2.8 vs. 4.0 ± 2.2 months, P = 0.34). Ultimate elbow ROM was similar between the study groups ( P = 0.48, P = 0.49, P = 0.61, and P = 0.51 for elbow extension, flexion, pronation, and supination, respectively). Free range of elbow motion without splinting produced similar results compared with elbow immobilization after surgical intervention for a fracture to the humerus, elbow, and forearm. There was no difference in patient-reported pain outcomes, wound problems, or elbow ROM. Immobilized patients reported slightly higher "healthscale" ratings than nonsplinted patients and, however, reported similar rates of satisfaction. Both treatment strategies are acceptable after upper extremity fracture surgery. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

A study to assess the relationship between vitamin D3 levels and the risk of acute exacerbation in patients with chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is one of the top three causes of mortality worldwide. Vitamin D deficiency in COPD has been associated with poor lung function and decreased muscle power, which further increases the risk of exacerbations. The role of vitamin D in preventing acute exacerbations of COPD has conflicting results in the literature. Hence, we planned this study to assess the relationship between vitamin D3 levels and the risk of acute exacerbations among COPD patients in a tertiary care center in north India. This was a prospective randomized control trial that was performed on 100 consecutive stable COPD patients attending the Department of Respiratory Medicine at Maharishi Markandeshwar Medical College and Hospital, Solan, India. The patients with subnormal vitamin D3 levels (i.e., less than 30 ng/mL) were divided into the intervention and control groups. Baseline demographic profiles, lung function, COPD assessment test (CAT) score, modified Medical Research Council grade and chest radiology were performed and repeated after 12 months in all these patients. All these parameters were recorded and compared with the baseline values obtained at the beginning of the study. Out of 100 subjects, 96 had vitamin D deficiency, of which 48 were assigned to the intervention group and 48 to the control group. Among the 100 subjects, 74 (74%) were males and 26 (26%) were females, with a mean age of 66.9±9.4 years. The mean vitamin D level was 14.71±6.69 in these 96 patients. The vitamin D level improved after 3 months of supplementation to the mean level of 45.56±16.18 in the intervention group. Vitamin D supplementation was positively correlated with a decrease in the rate of acute exacerbations in the intervention group in terms of reduction in mean CAT score (4.17 in intervention and 1.43 in non-interventional group, p<0.001), number of acute exacerbations (1.7 in intervention and -1.05 in non-interventional group, p<0.001), and number of emergency visits (p=0.0121) during the 9-month period after attainment of a normal vitamin D level. Vitamin D supplementation plays a key role in COPD patients with D3 hypovitaminosis in decreasing COPD acute exacerbations, improving the CAT score, and reducing the number of emergency visits.

Reverse Shoulder Arthroplasty or Nothing for Patients with Displaced Proximal Humeral Fractures. A Randomized Controlled Trial

The benefits of reverse shoulder arthroplasty compared to nonoperative treatment for patients presenting with complex proximal fractures have been rarely explored. The aim of this prospective study was to compare the functional results of reverse shoulder arthroplasty with those of nonsurgical treatment in patients with displaced proximal humeral fractures. A multicentric prospective randomized control trial of patients older than 70years who sustained an acute proximal humeral fracture (3 or 4 parts), with less than 3weeks of evolution, and had no previous condition or surgery on the affected shoulder was conducted. Patients were randomly assigned to the intervention group (implantation of a reverse shoulder arthroplasty and tuberosities reattachment) or the control group (nonoperative treatment). Functional outcome was assessed using the Constant-Murley score (CMS) at the 1-year follow-up. Complications and reinterventions were considered secondary outcomes. The power of the study relied on the inclusion of 81 patients to recognize a statistically significant difference of 10 points between CMS scores in the groups. Analysis was performed based on the intention to treat principle. Eighty-one patients were randomized to surgical treatment or nonoperative treatment, while 66 patients completed the 1-year follow-up evaluation. There was no significant difference between the groups in terms of age (76.1 yo vs. 77.43 yo, P=.43), sex (81.08% women in the surgical group vs. 84.09% in the nonoperative group, P=.72), or type of fracture according to Neer's classification system (P=.06). At the 1-year follow-up, the group assigned to undergo the intervention had better functional outcomes than the nonoperative treatment group (mean CMS; 61.24, SD: 13.33 vs. mean CMS: 52.44, SD: 16.22, P: .02), with a mean difference of 8.84 points, 95% CI (1.57, 16.11). Two patients in the intervention group (6.5%) suffered major complications (periprosthetic joint infection and axillary nerve palsy). No major complications were observed in the nonoperative group. One patient in the intervention group underwent secondary surgery for a periprosthetic joint infection. Treatment with reverse shoulder arthroplasty provides superior functional outcomes compared with conservative treatment for patients presenting with an acute proximal humeral fracture. The difference in CMS is close to the clinically significant thresholds, and some harms are associated with the operative treatment.

A comparison of intra-articular hyaluronic acid and platelet-rich plasma for knee osteoarthritis: a systematic review.

Knee osteoarthritis (KOA), the most common chronic degenerative condition in an older population, accounts for many disabilities around the world. One of the most popular treatments is intra-articular injection of hyaluronic acid (HA) and platelet-rich plasma (PRP). Prior studies have found that both HA and PRP had a therapeutic effect on KOA. This study aims to perform a systematic review regarding whether PRP is superior to HA for KOA. We conducted a comprehensive literature search using Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines for prospective randomized control trials (pRCTs) in three international databases PubMed, Google Scholar, and ScienceDirect from 2019-2022. Two researchers independently searched the reviews, extracted, and cross-checked the data. The disparity when choosing the literature was resolved by discussion. The modified Jadad was scale used to assess the quality of the included studies. Cochrane risk of bias 2 tool (RoB-2) was used for determininzg risk of bias. Twenty three studies were eligible for inclusion. Four pRCT with the highest Jadad score were selected as best evidence. Risk of bias assesment concluded two studies having a low risk of bias, one is high risk of bias, and the other possesses some concerns.. Three studies found no difference in patient-reported outcomes between PRP and HA group and one study concluded that PRP is more effective than HA in treating KOA. Intra-articular injections of PRP and HA are effective interventions for KOA. However, there is not enough evidence of PRP superiority over HA.

Risk Factors for Immune Checkpoint Inhibitor–Related Myocarditis: An Integrative Review

Purpose: The purpose of this integrative literature review was to determine factors that increase the risk of immune checkpoint inhibitor (ICI)–related myocarditis in the cancer patient population. Methods: A literature review was conducted using the following databases: PubMed, Scopus, and Cochrane Review. Dates searched were from inception through March 1, 2022. Inclusion criteria included English language, cancer patients receiving ICI treatment, and risk factors for myocarditis. Articles were excluded if they were a non-human study, duplicate, had an irrelevant title or content, or were a review or commentary. Results: Patients with cancer who receive ICIs have an associated increased risk of myocarditis if they are older than 64 years, have a body mass index (BMI) greater than 28, and have a history of cardiovascular medication use. Conclusions: Myocarditis remains a rare cardiovascular adverse effect of ICIs. However, the mortality risk among this subset of patients remains high. Additional prospective randomized-controlled trials would be beneficial to further determine a causal relationship between risk factors for ICI-related myocarditis. Risk stratification tools may allow oncology medical providers to identify patients at a higher risk of ICI-related myocarditis to increase earlier surveillance.

The Influence of Honey and Hydrogel Products Therapy on Healing Time in Diabetic Foot.

Diabetic foot ulcer is a serious and common complication of diabetes that often leads to significant morbidity and even amputation if not properly treated. Current treatment options, such as wound dressing, have limitations in promoting efficient healing. There is a need for effective interventions that can expedite the healing process and enhance the time required for complete healing. This prospective single-blinded randomized control trial studied diabetic mellitus type 2 patients with ulcer in their second-degree feet from February 2019 to February 2023 in the Diabetic Foot Center, King Fahad Specialist Hospital Al Qassim-KSA. This study involved 120 patients with a mean age of 59.64 ± 10.21. And 63% to 52.5% of them were males and 57% to 47.5% were females. The mean healing time was about 12.76 ± 4.08 days. Cases were divided into 4 equal groups with altered treatment procedures: honey alone, hydrogel alone, honey, and hydrogel combination alternately (3 intervention groups), and fucidin ointment or cream alone (1 control group), with 30 participants in each group. We revealed that the mean healing times for honey alone, hydrogel alone, and honey and hydrogel alternately were 12.20, 13.97, and 10.83 days, respectively. While it was 14.03 days in the control Fucidin ointment or cream [significantly P < .05 (P = .004)]. From the findings of the present study, we noticed that faster healing time among diabetic foot cases could be accomplished by treatment with a combination of honey and hydrogel alternately. Therefore, this therapy is effective in reducing the risk of diabetic foot ulcers.

Creatine supplementation for optimization of physical function in the patient at risk of functional disability: A systematic review and meta-analysis.

The efficacy of creatine replacement through supplementation for the optimization of physical function in the population at risk of functional disability is unclear. We conducted a systematic literature search of MEDLINE, EMBASE, the Cochrane Library, and CINAHL from inception to November 2022. Studies included were randomized controlled trials (RCTs) comparing creatine supplementation with placebos in older adults and adults with chronic disease. The primary outcome was physical function measured by the sit-to-stand test after pooling data using random-effects modeling. We also performed a Bayesian meta-analysis to describe the treatment effect in probability terms. Secondary outcomes included other measures of physical function, muscle function, and body composition. The risk of bias was assessed using the Cochrane risk-of-bias tool. We identified 33 RCTs, comprising 1076 participants. From six trials reporting the primary outcome, the pooled standardized mean difference (SMD) was 0.51 (95% confidence interval [CI]: 0.01-1.00; I2 = 62%; P = 0.04); using weakly informative priors, the posterior probability that creatine supplementation improves physical function was 66.7%. Upper-body muscle strength (SMD: 0.25; 95% CI: 0.06-0.44; I2 = 0%; P = 0.01), handgrip strength (SMD 0.23; 95% CI: 0.01-0.45; I2 = 0%; P = 0.04), and lean tissue mass (MD 1.08 kg; 95% CI: 0.77-1.38; I2 = 26%; P < 0.01) improved with creatine supplementation. The quality of evidence for all outcomes was low or very low because of a high risk of bias. Creatine supplementation improves sit-to-stand performance, muscle function, and lean tissue mass. It is crucial to conduct high-quality prospective RCTs to confirm these hypotheses (PROSPERO number, CRD42023354929).

An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial

BackgroundPatients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood intervention is a manualized and user-centered, digital intervention for patients with obesity, with a duration of 4 months, which contains elements of cognitive behavioral therapy and mindfulness-based and skills-based exercises. We expect the LightMood intervention to be superior to treatment as usual (TAU) in terms of reducing depression symptoms.MethodsThe trial incorporates four distinct measurement time points: the baseline assessment, the post-treatment assessment, and 1- and 3-month follow-up assessments. Furthermore, we implemented in-treatment assessments for both groups. Participants will be randomized into two groups (LightMood intervention vs TAU). The aim is to include 128 participants (64 per group) in the study. Inclusion criteria are patients who are obese, at least 18 years old, with a private Internet access, and with adequate digital literacy and show depression symptoms (PHQ ≥ 10). Exclusion criteria are weekly outpatient individual psychotherapy, obesity surgery within the last year or planned within the next 7 months, no private Internet access, and the prescription of a new psychotropic drug within the last 2 weeks. The primary outcome is the post-assessment reduction in depression symptoms. Secondary outcomes will include the improvement in self-efficacy, quality of life, mindfulness, reduction in eating disorder symptoms, and body mass index (BMI). Furthermore, we expect a positive development of depression symptoms throughout the different time points (T1, T2, and T3) in patients with obesity.DiscussionLightMood is an evidence-based, efficient, low-threshold online intervention that aims to reduce depression symptoms in people with obesity. Online interventions could offer a promising alternative to conventional face-to-face therapy. The primary objective of the current study is to add essential insight into the feasibility, efficacy, effectiveness, and acceptance of e-mental health interventions for people with obesity and depression symptoms.Trial registrationGerman Clinical Trial Register (DRKS), DRKS00029219. Registered on May 19, 2023

A randomized control trial for evaluation of transfusion related immuno-modulation in patients with meningioma

BackgroundBlood transfusion necessity in neurosurgery varies based on surgical type, blood loss, and patient anemia. Leukocytes in red blood cells (RBCs) component release pro-inflammatory cytokines during storage, contributing to transfusion-related immunomodulation (TRIM). Our aim was to examine the impact of the leukocyte content in transfused PRBCs on patients undergoing neurosurgery for meningioma tumours. Study design and methodsThis prospective randomized controlled trial conducted from 2018 to 2020 by dividing patients randomly into non-leukoreduced (NLR) (n = 65) and leuko-reduced (LR) (n = 65) groups based on PRBCs received during surgery and hospital stay. Hospital and ICU stays, mechanical ventilation duration, and postoperative bacterial infections were observed. Hematological parameters and cytokine levels (IL-10, INF-gamma, and FAS-L) were assessed at pre-transfusion, 24 h, and 7 days post-transfusion. Data analysis included Mann-Whitney U test, Friedman test, Fisher's chi-square test, with statistical significance at p < 0.05. ResultsIn our study, ICU and hospital stay duration showed no significant difference (p = 0.06) between groups. However, NLR group had longer mean mechanical ventilation (18 ± 40.1 h) than the LR group (12.8 ± 8.6 h). Both groups showed statistically significant increase in Fas-L level on days 1 and 7 (p < 0.05). The IL-10 levels rose 43% in the NLR group, while and decreased by 7% the LR group on day 1. On day 7, IL-10 increased by 75% in NLR and decreased by 40% in LR, with no significance (p > 0.05). ConclusionIn conclusion, leukoreduction appeared to offer some immune response protection in term of reducing mechanical ventilation timings and cytokine level changes.

A139 EARLY VIDEO CAPSULE ENDOSCOPY VERSUS COLONOSCOPY FOLLOWING NEGATIVE ESOPHAGOGASTRODUDENOSCOPY IN PATIENTS WITH SUSPECTED UPPER GASTROINTESTINAL BLEEDING: PRELIMINARY DATA FROM A RANDOMIZED CONTROLLED TRIAL

Abstract Background Esophagogastroduodenoscopy (EGD) is recommended for initial endoscopic evaluation of patients with suspected upper gastrointestinal bleeding (UGIB). When this is negative, the standard recommendation is to perform a colonoscopy, despite low diagnostic yield of less than 5%. In these patients, the question remains as to whether small bowel investigations would be of higher yield prior to colonoscopy. Aims To compare the diagnostic yield between early video capsule endoscopy (VCE) versus colonoscopy after a negative EGD in patients with suspected UGIB. Methods This is preliminary data from a prospective randomized control trial (RCT) of adult patients with suspected UGIB (melena and hemoglobin drop of more than 20 g/L within 48 hours of admission). Patients at a single centre were enrolled prior to initial EGD; those with negative EGD were included and randomized to either colonoscopy (next day) or early VCE (immediately after EGD). Patients with a confirmed source of bleeding in their group required no further testing, but those without underwent further testing with the alternative (VCE or colonoscopy). We evaluated patient outcomes, including bleeding localization time, hospitalization duration, procedure count, complications and rebleeding rates. Results A total of 19 adult patients have been enrolled, of which 12 had negative EGD and were randomized to either VCE or colonoscopy, with six patients in each arm (Figure 1). In the VCE group, 100% (6/6) of patients had bleeding sources detected by early VCE, with 50% (3/6) of them undergoing endoscopic treatment. In the colonoscopy group, only one patient had a positive finding (1/6), the rest underwent subsequent VCE. The VCE identified the bleeding source in 80% (4/5) of patients with negative colonoscopy. Patient are outlined in Table 1. Conclusions Based on our preliminary data, the diagnostic yield of early and subsequent VCE was higher when compared to colonoscopy after initial negative EGD in patients with suspected UGIB. Table 1. Summary of findings and patient outcomes Funding Agencies Medtronic Canada (Brampton, ON, CA) will provide the video capsule in the treatment group. This is the only equipment funding required in this study.

A128 OPTIMIZED COMPUTER ASSISTED TECHNIQUE FOR INCREASING ADENOMA DETECTION DURING COLONOSCOPY: A RANDOMIZED CONTROLLED TRIAL

Abstract Background Efforts to improve colonoscopy have recently focused on improving adenoma detection interventions such as artificial intelligence (CADe) that have demonstrated improvements in Adenoma Detection Rates (ADR). Although studies have focused on implementation of one intervention at a time. Aims We evaluated an optimized computer assisted technique (CADopt) versus standard colonoscopy to improve ADR during colonosocopy. Methods A prospective randomized controlled trial was conducted enrolling adults (45–80 years) undergoing elective colonoscopy. Participants were randomized (1:1) to the intervention group (CADopt, and control group. In the CADopt group, endoscopists used a computer aided polyp detection combined with linked colour imaging, water exchange colonoscopy, and cecal retroflexion. In the control group, standard colonoscopy was performed. Primary outcome was Adenoma Detection Rate (ADR) in the intervention and control groups. Secondary outcomes included advanced ADR (AADR) and sessile serrated lesion detection rates (SDR). Results A total of 467 patients were recruited and randomized (CADopt group 229 patients, 50.2% female vs 238 patients, 48.3% female in the control group). ADR was 49.3% (95%CI 42.7-56.0) for the CADopt group vs 38.2% (95%CI 32.0-44.7) for the control group (p=0.016). AADR and SDR were 13.1% (95%CI 9.0-18.2) and 6.6% (95%CI 3.7-10.6) for the CADopt group versus 8.0% (95%CI 4.9-12.2), and 7.1% (95%CI 4.2-11.1) for the control group, respectively. Conclusions Using an optimized computer assisted technique led to significant improvements in ADR and a trend towards AADR improvements. Funding Agencies Fujifilm

Impact of Peri-Operative Blood Transfusion on Post-Operative Complications in Colorectal Surgery

Aim: Colorectal cancer (CRC) is commonly associated with anaemia often requiring perioperative blood transfusions (BT). There is significant evidence to show poor long term outcomes following BT in CRC surgery due to the immunomodulatory effects of BT. This study aims to analyse the impact of BT on post-operative surgical complications in CRC surgery. Method: Data were collected retrospectively for patients undergoing emergency and elective colorectal cancer related surgery between January 2019 and December 2020 at Blacktown Hospital, Sydney. Data relating to transfusion and post-operative complications were collected through electronic medical records. R statistical software was utilised to calculate hazard ratio of common surgical complications in the blood transfusion group compared to the non-blood transfusion group. Results: There were a total of 130 patients with 26 patients (20%) receiving BT. This study shows that BT is associated with an increased risk of post-operative complication in CRC surgeries [HR 3.74 (95% CI: 1.31-10.68; P=0.0073)], after adjusting for preoperative haemoglobin. In particular, this study shows a statistically significant higher rates of intra-abdominal collection [HR 12.98 (95% CI: 1.52-111.15; P=0.0114)]. and pneumonia [HR 21.65 (95% CI: 1.77-265.01; P=0.007994)] associated with blood transfusion. Conclusion: This study shows that BT is associated with an increased risk of post-operative complication particularly intra-abdominal collection and pneumonia. However, a prospective randomised control trial is required to confirm these results.

Analysis of Effect of Melatonin on Postoperative Sensory Nerve Recovery Following Open Reduction and Internal Fixation of Anterior Mandible Fractures: A Prospective Randomized Control Trial.

Open reduction and internal fixation (ORIF) of the anterior mandibular fractures are commonly associated with mental nerve paraesthesia. This study evaluates the efficacy of melatonin on postoperative sensory functional recovery and pain following surgical treatment of anterior mandibular fractures. Forty patients were randomly allocated to two groups: Group I-melatonin, and Group II-control group. Postoperative neurosensory recovery was evaluated both subjectively and objectively at 1-week, 1-month, and 3-month intervals. The pain was assessed during the immediate postoperative period, postoperative days 1, 2, 3, and 7 using a visual analog scale. Statistical significance was set at P value < 0.05. The statistically significant difference was noticed in both subjective and objective recovery of sensory nerve function at 1-month follow-up. All patients in the melatonin group showed complete recovery of nerve function as compared to the control group where 10% of patients showed limited recovery. Neurosensory recovery following ORIF of mandibular fractures was better in the melatonin group as compared to the control group and therefore the perioperative administration of 10mg. Melatonin can be recommended for quicker and better nerve recovery in the anterior mandibular fractures requiring close manipulation of the mental nerve during treatment.

The effect of music on pain management in preterm infants during daily painful procedures: a systematic review and meta-analysis.

The present systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to investigate the effects of music on pain management in preterm neonates during painful procedures. The PubMed, Embase, Web of Science, EBSCO and Cochrane Library databases were searched to identify relevant articles published from their inception to September 2023. The study search strategy and all other processes were implemented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Four RCTs that satisfied the inclusion criteria were included in this meta-analysis. The music group had significantly lower Premature Infant Pain Profile (PIPP) scores during (RR = -1.21; 95% CI = -2.02--0.40, p = 0.0032) and after painful procedures (RR = -0.65; 95% CI = -1.06--0.23, p = 0.002). The music group showed fewer changes in PIPP scores after invasive operations than did the control group (RR = -2.06; 95% CI -3.16--0.96; p = 0.0002). Moreover, our results showed that music improved oxygen saturation during (RR = 3.04, 95% CI = 1.64-4.44, p < 0.0001) and after painful procedures (RR = 3.50, 95% CI = 2.11-4.90, p < 0.00001). However, the change in peak heart rate during and after painful procedures was not statistically significant (RR = -12.14; 95% CI = -29.70-5.41 p = 0.18; RR = -10.41; 95% CI = -22.72-1.90 p = 0.10). In conclusion, this systematic review demonstrated that music interventions are effective for relieving procedural pain in preterm infants. Our results indicate that music can reduce stress levels and improve blood oxygen saturation. Due to the current limitations, large-scale, prospective RCTs should be performed to validate the present results.

QSOFA combined with suPAR for early risk detection and guidance of antibiotic treatment in the emergency department: a randomized controlled trial

BackgroundSepsis guidelines suggest immediate start of resuscitation for patients with quick Sequential Organ Failure Assessment (qSOFA) 2 or 3. However, the interpretation of qSOFA 1 remains controversial. We investigated whether measurements of soluble urokinase plasminogen activator receptor (suPAR) may improve risk detection when qSOFA is 1.MethodsThe study had two parts. At the first part, the combination of suPAR with qSOFA was analyzed in a prospective cohort for early risk detection. At the second part, the double-blind, randomized controlled trial (RCT) SUPERIOR evaluated the efficacy of the suPAR-guided medical intervention. SUPERIOR took place between November 2018 and December 2020. Multivariate stepwise Cox regression was used for the prospective cohort, while univariate and multivariate logistic regression was used for the RCT. Consecutive admissions at the emergency department (ED) with suspected infection, qSOFA 1 and suPAR ≥ 12 ng/mL were allocated to single infusion of placebo or meropenem. The primary endpoint was early deterioration, defined as at least one-point increase of admission Sequential Organ Failure Assessment (SOFA) score the first 24 h.ResultsMost of the mortality risk was for patients with qSOFA 2 and 3. Taking the hazard ratio (HR) for death of patients with qSOFA = 1 and suPAR < 12 ng/mL as reference, the HR of qSOFA = 1 and suPAR ≥ 12 ng/mL for 28-day mortality was 2.98 (95% CI 2.11–3.96). The prospective RCT was prematurely ended due to pandemia-related ED re-allocations, with 91 patients enrolled: 47 in the placebo and 44 in the meropenem arm. The primary endpoint was met in 40.4% (n = 19) and 15.9% (n = 7), respectively (difference 24.5% [5.9–40.8]; odds ratio 0.14 [0.04–0.50]). One post hoc analysis showed significant median changes of SOFA score after 72 and 96 h equal to 0 and − 1, respectively.ConclusionsCombining qSOFA 1 with the biomarker suPAR improves its prognostic performance for unfavorable outcome and can help decision for earlier treatment.Trial registration EU Clinical Trials Register (EudraCT, 2018-001008-13) and Clinical-Trials.gov (NCT03717350). Registered 24 October 2018.

Network Meta-analysis of Chinese patent medicine in treatment of heart failure with preserved ejection fraction

This study systematically evaluated the efficacy and safety of different Chinese patent medicines combined with conventional western medicine in the treatment of heart failure with preserved ejection fraction(HFpEF) and ranked for the drug selection. Randomized controlled trial(RCT) on Chinese patent medicines in treatment of HFpEF were obtained from the CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, Web of Science, and other databases from the inception to October 9, 2022. The included RCT was quantitatively analyzed using gemtc and rjags packages of R software for the network Meta-analysis. 74 RCTs were included, with a total of 7 192 patients enrolled, involving 11 different Chinese patent medicines(Shenfu Injection, Shenmai Injection, Qili Qiangxin Capsules, Shexiang Baoxin Pills, Xuezhikang Capsules, Salvia Miltiorrhiza Polyphenols Injection, Tanshinone Ⅱ_A Sulfonate Injection, Xinmailong Injection, Yangxinshi Tablets, Qishen Yiqi Dripping Pills, and Yixinshu Capsules). The results of network Meta-analysis are shown as followed.(1)In terms of improving clinical effective rate, for injection preparations, Xinmailong Injection + conventional western medicine was recommended. while for oral preparations, Shexiang Baoxin Pills + conventional western medicine, Qishen Yiqi Dripping Pills + conventional western medicine, and Qili Qiangxin Capsules + conventional western medicine were preferred.(2)In terms of improving the mitral ratio of peak early to late diastolic filling velocity(E/A), for injection preparations, Shenmai Injection + Salvia Miltiorrhiza Polyphenols Injection + conventional western medicine, Shenmai Injection + conventional western medicine, Shenfu Injection + conventional western medicine were preferred. While for oral preparations, Yixinshu Capsules + conventional western medicine was preferred.(3)In terms of reducing the ratio of early diastolic mitral inflow to early diastolic mitral annular velocity(E/e'), Shenfu Injection + conventional western medicine could be used as injection preparation, and Qili Qiangxin Capsules + conventional western medicine, Qishen Yiqi Dripping Pills + conventional western medicine for oral preparations.(4)In terms of improving 6-minute walking trail(6MWT), the injection preparations such as Shenmai Injection + conventional western medicine, Xinmailong Injection + conventional western medicine were suitable, while oral preparations like Qishen Yiqi Dripping Pills + conventional western medicine, Qili Qiangxin Capsules + conventional western medicine were recommended.(5)In terms of reducing N-terminal pro B-type natriuretic peptide(NT-proBNP), Qili Qiangxin Capsules + conventional western medicine were preferred.(6)In terms of reducing B-type natriuretic peptide(BNP), Xinmailong Injection + conventional western medicine could be used for injection preparation and Qili Qiangxin Capsules + conventional western medicine can be used for oral preparation. In terms of adverse drug reactions, there was no significant difference between Chinese patent medicine combined with conventional western conventional and traditional western medicine alone. The results showe that Chinese patent medicine combined with conventional western medicine in treating HFpEF is superior to conventional western medicine alone in reducing clinical symptoms, improving cardiac function, and improving exercise tolerance, which also has good drug safety. However, the existing evidence is still limited by the quality and quantity of included studies, so the above conclusion requires further validation through more prospective RCT.