Randomized Pilot Study Research Articles

A prospective double-blind clinical study: Effect of probiotics and thalidomide on radiation enteritis in patients with pelvic cancer undergoing concurrent chemoradiotherapy.

e23013 Background: Radiation induced diarrhea (RID) is one of the commonest and most distressing side effects during and after radiotherapy predominantly in patients whose irradiation region is pelvis. Thalidomide reduces severity as well as the frequency indicated in RID but mechanism of action is not elucidated. Probiotics are beneficial microorganisms that may regulate flora of intestines to increase immunity and have a protective effect on RID. This pilot study was designed to ascertain effects of thalidomide and probiotics on RID in patients being subjected to pelvic irradiation. Methods: A double-blind, single-center, randomized pilot study was conducted. Patients were classified into two groups as thalidomide plus probiotics (Lactobacillus rhamnosus + Probio-M9, ) group (TP group) or plus placebo group (P group).Incidence of grade 3/4 diarrhea, was a primary endpoint of the study. Other secondary endpoints analyzed were rates and severity of diarrhea, antibiotics use, body weight, albumin, and lymphocyte changes. 31 patients undergoing pelvic radiotherapy with or without concurrent chemotherapy were randomly selected from government tertiary general hospital. Results: The incidence of grade 3/4 diarrhea was 9.5% (95% CI: 0 to 24.5%) in TP, which was significantly different from historical data of 30% to 60%. The incidence of grade 3/4 diarrhea in group P was 19.8% (95% CI: 0~41.3%). The frequency and severity of diarrhea in group TP were little less than in group P. There is no significant difference between them. Basically, the time for antibiotic use in groups P and TP was the same, with a slightly longer time from first antibiotic exposure in group TP as compared to group P. The moment of first antibiotics have been prescribed in our study patients, this was better than that of a clinical routine treatment experience and other research data according to the literature. The changes in body weight, albumin level, and lymphocyte at different stages before and after radiotherapy in group TP were not statistically significant, and the level of body weight and albumin in group P was slightly reduced compared with before radiotherapy but increased compared with group TP after radiotherapy. Furthermore, there were no severe adverse effects regarding thalidomide as well as probiotics reported among patients who participated in this study. Conclusions: The combined treatment with thalidomide and probiotics is beneficial to ameliorate RID in patients receiving pelvic radiotherapy, yet this study can't represent whole conclusion due to small size of patients. We will also need larger, multicenter double-blind placebo-controlled trials to confirm exact efficacy and safety of this combined treatment. Clinical trial information: NCT05059613 .

Randomized pilot study assessing the safety and tolerability hyperthermic intraperitoneal chemotherapy (HIPEC) at completion of interval cytoreductive surgery or chemotherapy the day prior to interval cytoreductive surgery for patients with stage III/IV ovarian cancer undergoing neoadjuvant chemotherapy.

TPS5638 Background: A recent randomized phase III trial demonstrated an improvement in recurrence free and overall survival when heated intraperitoneal chemotherapy (HIPEC) was given at the time of interval cytoreductive surgery (iCRS) for advanced ovarian cancer. While there is rationale for HIPEC’s mechanism of effect, it remains unclear whether the observed benefit is because the chemotherapy schedule is not interrupted perioperatively (typically at least 6-8 weeks). We hypothesize that administration of the same agent and similar dose the day before surgery, will not increase toxicity and may improve feasibility for closing the gap between treatment cycles, while also limiting length of surgery and time under anesthesia. The primary objective of this study is to assess the feasibility, safety, and tolerability of IV Cisplatin the day prior to iCRS compared to HIPEC to determine if this is an acceptable alternative. Methods: This is a single institution randomized Pilot Study (NCT05415709). Patients with newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube, or peritoneal cancer are eligible if they achieve a partial or complete response to 3-4 cycles of neoadjuvant carboplatin/paclitaxel +/- bevacizumab and are deemed to have disease amenable to a complete or optimal iCRS. Patients are scheduled for iCRS within 3-4 weeks following the third or fourth cycle and randomized 1:1 to IV Cisplatin (75 mg/m2) given the day prior to iCRS or HIPEC with Cisplatin (100 mg/m2) given intraoperatively over 90 min at 40°Celsius at the completion of surgical debulking. 15 patient per arm are planned (N=30); currently 7 patients have completed study interventions. No formal power calculation was required for this feasibility and safety study. Frequency and severity of adverse events (AEs) and tolerability of the regimens will be collected and summarized by descriptive statistics for each group. Patients who are able to receive planned treatment will be summarized as percentage for each treatment group. Accrual is anticipated to complete in June 2025. As an exploratory secondary endpoint, we plan to explore changes to the gut microbiome before and after HIPEC and examine correlative patterns with response and toxicity. Clinical trial information: NCT05415709 .

Randomized Pilot Trial of Pre- and Postoperative Heart Failure Nurse-Supported Care in Heart Failure Patients Requiring Noncardiac Surgery-Feasibility and Results.

The perioperative cardiovascular management of patients undergoing noncardiac surgery is particularly challenging in those with pre-existing heart failure (HF). This study was designed to evaluate the effectiveness of nurse-based pre- and postoperative specialized HF management in reducing postoperative HF-associated complications in patients with known HF undergoing noncardiac surgery. This prospective, randomized pilot study included patients with established HF requiring intermediate- to high-risk noncardiac surgery. Patients received postoperatively either standard care (control group, CG) or nurse-supported HF management (intervention group, IG). The primary endpoint was a composite of HF-related postoperative complications at 30 days. Secondary endpoints included length on intensive care unit, length of hospital stay, death, hospitalization for HF, and quality of life assessment using the SF-12 questionnaire. The trial was halted prematurely for futility. A total of 34 patients (median age 70.5 [IQR 67-75] years; with 15 HfpEF, 9 HfmrEF,10 HfrEF), with an average NT-proBNP of 1.413 [463-2.832] pg/mL were included. The IG had a lower rate of postoperative primary events (25%; n = 4) compared with the CG (33%; n = 6). There were no differences in secondary endpoints between the groups. Quality-of-life scores improved slightly in both groups (δ 5.6 ± 0.9 [CG] and 3.1 ± 1.2 [IG]). Nurse-based pre- and postoperative HF care appears to be feasible and may reduce HF-associated complications in patients undergoing noncardiac surgery. Larger clinical trials are needed to further evaluate the effectiveness of this approach in reducing postoperative complications in this high-risk patient population.

A Pilot and Feasibility Study to Evaluate the Effectiveness of Tofacitinib Add-On Therapy to Remdesivir in Severely Ill COVID-19 Patients.

This placebo-controlled and randomized pilot study aimed to assess the feasibility and impact of tofacitinib/remdesivir combination therapy compared to remdesivir alone on clinical and laboratory findings of severely ill COVID-19 patients for future large-scale studies. Fifty patients were included in this study. They were randomly allocated into two groups of 25 subjects each. Patients in the treatment group received a five-day course of tofacitinib (10 mg twice daily) in addition to a five-day course of remdesivir, whereas the control group received a 10-day course of remdesivir with a placebo. There was no significant difference in rates of need for intubation (oxygen saturation level), intensive care unit (ICU) admission, death and length of hospitalization between the two groups (P>0.05). Nevertheless, the PRIEST severity score was significantly reduced in the treatment group compared to the control group (P=0.03, effect size [95% CI]: -0.616 [0.0233-1.1723]). Moreover, the mean level of C-reactive protein after 10 days was significantly decreased in the treatment group but increased in the control group (P=0.006). Tofacitinib adopted in this pilot study modulate the inflammation and reduce the PRIEST score in severe COVID-19 patients. So, it is feasible and could be applied in future larger-scale trials to precisely determine its effects on coronavirus infections.

Vein of Marshall ethanol infusion related lesion durability. A randomized dual centre pilot study

Abstract Introduction Vein of Marshall ethanol infusion (VOM-EI) creates a local ablation which includes epicardial bridges, AF triggers, vein innervation and facilitates mitral isthmus (MI) ablation. Recent trials demonstrated that in persistent AF patients the addition of VOM-EI to RF catheter ablation (CA) increased success rate vs CA alone. Moreover, a novel CA strategy (VOM-EI, PVI, and specific linear lesions set) is associated with a high rate of freedom from AF. Nevertheless, in these studies VOM-EI and RFCA were performed as different step of the same procedure. We hypothesize that performing electro-anatomical mapping (EAM) right after the VOM-EI would lead to an overestimation of ethanol-induced scar because of a certain amount of reversible oedema. This could affect the durability of the lesion set and possibly the success rate. Aim We postulated that VOM-EI performed at least 1 month earlier than RFCA would show a significantly smaller EAM low voltage area as compared to the standard strategy. Methods Patients with recurrent persistent AF with no history of previous ablation were enrolled in this randomized, dual centre, pilot study. All included patients were randomized 1:1 to group 1 (experimental): VOM-EI and after at least one month later high-definition (HD)-EAM and RFCA (PVI, MI, LA dome, cavo-tricuspid isthmus). group 2 (control): to a standard procedure (VOM-EI then 5 minute later HD-EAM and RFCA). Primary endpoint was ethanol induced HD-EAM scar area. According to the endpoint patients with unsuccessful VOM-EI were excluded. Moreover patiets with or no branches morphology, VOM dissection, and mechanical leakage were also excluded because these are demonstrated to be related to a smaller VOM-EI related lesion. Clinical and procedure related data were also collected. Results Forty consecutive patients met the inclusion criteria. The two groups did not differ for baseline characteristics (see table 1). Mean ethanol-induced HD-EAM scar area was significantly smaller in 20 patients where VOM-EI was performed at least 1 month earlier as compared to the standard procedure group (2,5±2,4 vs 11,2±9,5 cm2, p=0,018). The set of linear lesions was successful achieved in all patients. Notably the two group did not differ for any procedural technical aspect of mitral isthmus block (table 1). Neither VOM-EI nor AF ablation procedure related complications were recorded. Conclusion This is the fist randomized pilot study to demonstrate that a consistent amount of ethanol-induced related lesion could be reversible at least in its endocardial aspect of the left atrium. This would possibly affect the long-term stability of the lesion set. Notably, we still had a high rate of block at first mitral line attempt which could possibly be related to a persistent effect of VEOM-EI on the epicardial aspect of the left atrium. Larger population, randomized trial is needed to confirm this preliminary result and if it would affect the procedure success.Table 1Picture 1

#976 Empagliflozin limits AKI incidence and severity following cardiac surgery: an open-label phase IV randomized pilot study

Abstract Background and Aims Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication of cardiac surgery assisted by cardiopulmonary bypass (CPB). Currently, no effective preventative strategies exist to reduce the incidence of acute kidney injury (AKI). Sodium-glucose transport protein 2 (SGLT2) inhibitors are effective in reducing the incidence of AKI in studies conducted in patients with chronic kidney disease. Therefore, we hypothesized that perioperative SGLT2 inhibition could reduce the incidence of CSA-AKI. Method In this open-label phase IV, randomized, parallel-group, balanced (1:1), pilot study, adult patients undergoing elective cardiac surgery with CPB were randomized to receive 10 mg empagliflozin per os once daily three days before surgery until two days after surgery, or standard care. The primary outcome was AKI incidence according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Other outcomes included hypoxia-inducible factor 1 alpha (HIF1A) and urinary Kidney Injury Molecule (KIM-1), urinary neutrophil gelatinase associated lipocalin (NGAL) and metabolic parameters such as plasma ketone and glucose concentrations. Results Between March 2022 and April 2023, 60 patients were randomized to empagliflozin (n = 29) or control (n = 31). All patients who underwent cardiac surgery with CPB were included in the intention-to-treat analysis (n = 25; empagliflozin group, n = 30; control group). SGLT2 inhibition significantly reduced the incidence of all stages of AKI (20% vs 66.7%; absolute difference 46%, 95% CI .13 to .63, P < .001). This decline in AKI incidence was reflected in the kidney biomarkers. SGLT2 inhibition also significantly reduced the number of patients with postoperative hyperglycemia (28% vs 60%; absolute difference 32%, 95% CI −56.8 to −7.2, P = .029). We observed no differences in the incidence of neither ketoacidosis nor hypoglycemic events. Conclusion Perioperative SGLT2 inhibition, compared with standard of care, demonstrated a significant reduction in AKI incidence rates. These findings merit validation in a larger placebo-controlled trial which is currently ongoing. Supplementary figures:

Implementing an evidence-based behavioral weight-loss program in community mental health centers: A randomized pilot study.

Obesity is a leading cause of preventable death among individuals with serious mental illness (SMI). A prior randomized controlled trial demonstrated the efficacy of a lifestyle style intervention tailored to this population; however, such interventions need to be adapted and tested for real-world settings. This study evaluated implementation interventions to support community mental health program staff to deliver an evidence-based lifestyle intervention to clients with obesity and SMI. In this cluster-randomized pilot trial, the standard arm combined multimodal training with organizational strategy meetings and the enhanced arm included all standard strategies plus performance coaching. Staff-coaches delivered a 6-month group-based lifestyle intervention to clients with SMI. Primary outcomes were changes in staff knowledge, self-efficacy, and fidelity scores for lifestyle intervention delivery. Linear mixed-effects modeling was used to analyze outcomes, addressing within-site clustering and within-participant longitudinal correlation of outcomes. Three sites were in the standard arm (7 staff-coaches); 5 sites in the enhanced arm (11 staff-coaches). All sites delivered all 26 modules of the lifestyle intervention. Staff-coaches highly rated the training strategy's acceptability, feasibility and appropriateness. Overall, mean knowledge score significantly increased pre-post by 5.5 (95% CI: 3.9, 7.1) and self-efficacy was unchanged; neither significantly differed between arms. Fidelity ratings remained stable over time and did not differ between arms. Clients with SMI achieved a mean 6-month weight loss of 3.8 kg (95% CI: 1.6, 6.1). Mental health staff delivering a lifestyle intervention was feasible using multicomponent implementation interventions, and preliminary results show weight reduction among clients with SMI. The addition of performance coaching did not significantly change outcomes. Future studies are needed to definitively determine the effect on client health outcomes.

Organokines and liver enzymes in adolescent girls with polycystic ovary syndrome during randomized treatments.

Polycystic ovary syndrome (PCOS) is often associated with metabolic-associated fatty liver disease (MAFLD). MAFLD has been associated with altered hepatic function, systemic dysmetabolism, and abnormal circulating levels of signaling molecules called organokines. Here, we assessed the effects of two randomized treatments on a set of organokines in adolescent girls with PCOS and without obesity, and report the associations with circulating biomarkers of liver damage, which were assessed longitudinally in the aforementioned studies as safety markers. Liver enzymes [aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT)] were assessed as safety markers in previous randomized pilot studies comparing the effects of an oral contraceptive (OC) with those of a low-dose combination of spironolactone-pioglitazone-metformin (spiomet) for 1 year. As a post hoc endpoint, the organokines fibroblast growth factor-21 (FGF21), diazepam-binding protein-1 (DBI), and meteorin-like protein (METRNL) were assessed by ELISA after 6 months of OC (N = 26) or spiomet (N = 28). Auxological, endocrine-metabolic, body composition (using DXA), and abdominal fat partitioning (using MRI) were also evaluated. Healthy, age-matched adolescent girls (N = 17) served as controls. Circulating ALT and GGT levels increased during OC treatment and returned to baseline concentrations in the post-treatment phase; in contrast, spiomet treatment elicited no detectable changes in ALT and GGT concentrations. In relation to organokines after 6 months of treatment, (1) FGF21 levels were significantly higher in PCOS adolescents than in control girls; (2) DBI levels were lower in OC-treated girls than in controls and spiomet-treated girls; and (3) no differences were observed in METRNL concentrations between PCOS girls and controls. Serum ALT and GGT levels were directly correlated with circulating METRNL levels only in OC-treated girls (R = 0.449, P = 0.036 and R = 0.552, P = 0.004, respectively). The on-treatment increase in ALT and GGT levels occurring only in OC-treated girls is associated with circulating METRNL levels, suggesting enhanced METRNL synthesis as a reaction to the hepatic changes elicited by OC treatment. https://doi.org, identifiers 10.1186/ISRCTN29234515, 10.1186/ISRCTN11062950.

Effects of d-alanine Intake on Amino Acid Metabolism and Kidney Function in Healthy Adults: A Multicenter, Randomized Pilot Study

Backgroundd-alanine administration prevented kidney damage in a murine acute kidney injury model. Further data are needed on the influence of d-alanine on kidney function in humans. ObjectiveThis study investigated the effects of d-alanine intake on amino acid metabolism and kidney function in healthy volunteers. MethodsThis multicenter pilot study randomly assigned individuals from the general Japanese population to receive 3 g or 6 g of d-alanine intake per day for 7 d in a 1:1 ratio. The primary endpoint was the mean change in plasma and urine d-alanine levels from baseline to 7 d after intake. The secondary endpoints were mean changes in kidney function and other clinical factors. Safety was assessed by evaluating adverse events and clinical parameters. ResultsWe randomly assigned 24 participants to the 3-g (n = 12) and 6-g d-alanine (n = 12) groups. The mean baseline estimated glomerular filtration rate (eGFR) was 73 mL/min/1.73 m2. The mean plasma d-alanine concentration increased from baseline by 77.5 ± 34.3 and 192.1 ± 80.9 nmol/mL in the 3-g and 6-g d-alanine groups (both p < 0.0001), respectively, in a dose-dependent manner (between-group difference: 114.6 nmol/mL; 95% CI: 62.1–167.2; P = 0.0002). A similar increase was observed for the urine d-alanine to creatinine ratio. The mean eGFR was elevated by 5.7 ± 8.8 mL/min/1.73 m2 in the 6-g d-alanine group (P = 0.045) but did not significantly change in the 3-g d-alanine group. Nonserious adverse events were reported in 11 participants. Conclusionsd-alanine intake increased plasma and urine d-alanine levels and was well tolerated in participants with normal kidney function. These results will be useful in future trials investigating the effects of d-alanine intake on kidney disease progression in patients with chronic kidney disease.This trial was registered at the UMIN Clinical Trials Registry as UMIN000051466.

Comparison of Two Types of Endometrial Scratch before Embryo Transfer and Patient-Reported Pain Scores: A Prospective Randomized Pilot Study

Background: The impact of various methods of endometrial scratch during assisted reproductive technology (ART) is not well established. Objective: To compare patient-reported pain scores and ART outcomes following two types of endometrial scratch prior to embryo transfer. Study design: In this prospective, non-blinded, randomized controlled trial, patients were assigned to either Pipelle or Shepard catheter. The primary outcome was mean pain score. Secondary outcomes included implantation rate (IR) and clinical pregnancy rate (CPR). Results: One hundred seventy transfers were included (Pipelle: n=78, Shepard: n=92). Mean pain scores were significantly lower in the Shepard group compared to the Pipelle group (3.0±2.4 vs. 3.9±2.2, respectively; p=0.01). There was no significant difference in IR (Shepard: 59.7%±52 and Pipelle: 56.5%±48; p=0.9) and CPR (Shepard: 67.6%±47 and Pipelle: 71.8%±45; p=0.6). Conclusions: In our study, the Shepard catheter was a less painful method of endometrial scratch without compromising ART outcomes.

A Sensor-Based Upper Limb Treatment in Hemiplegic Patients: Results from a Randomized Pilot Study.

In post-stroke patients, the disabling motor deficit mainly affects the upper limb. The focus of rehabilitation is improving upper limb function and reducing long-term disability. This study aims to evaluate the feasibility of using the Gloreha Aria (R-Lead), a sensor-based upper limb in-hospital rehabilitation, compared with conventional physiotherapist-led training in subacute hemiplegic patients. Twenty-one patients were recruited and randomised 1:1 to a sensor-based group (treatment group TG) or a conventional group (control group, CG). All patients performed 30 sessions of 30 min each of dedicated upper limb rehabilitation. The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) was the primary evaluation., both as a motor score and as individual items. Secondary evaluations were Functional Independence Measure; global disability assessed with the Modified Barthel Index; Motor Evaluation Scale for UE in stroke; power grip; and arm, shoulder, and hand disability. All the enrolled patients, 10 in the TG and 11 in the CG, completed all hand rehabilitation sessions during their hospital stay without experiencing any adverse events. FMA-UE scores in upper limb motor function improved in both groups [delta change CG (11.8 ± 9.2) vs. TG (12.7 ± 8.6)]. The score at T1 for FMA joint pain (21.8 vs. 24 best score) suggests the use of the Gloreha Aria (R-Lead) as feasible in improving arm function abilities in post-stroke patients.

Effect of pelvic floor fascial mobilization on pelvic floor dysfunction in multiparous pregnant women - A randomized pilot study

BackgroundPelvic floor fascial mobilization (PFFM) is an innovative intravaginal and/or intrarectal manual therapy technique developed to treat pelvic distress by improving fascial gliding and muscle function. AimThe effect of PFFM on pelvic floor distress during pregnancy was compared to conventional pelvic floor muscle training. MethodsA pilot prospective randomized clinical trial. The primary outcome was the strength and function of the pelvic floor muscles measured via the Oxford grading scale, perineometry, and hip range of motion. Each subject was treated twice, one week apart. ResultsForty multiparous pregnant women at 24–30 weeks gestation, with pelvic distress, were allocated to PFFM (study group (n = 20)) vs. pelvic floor muscle training (control group (n = 20)). There was no difference in the severity of pelvic distress between the study and control groups before the interventions (PFDI-20: 27.1 ± 12.2 vs. 26.0 ± 13.5, respectively, p = 0.7). Twenty-six subjects completed the study protocol. PFDI-20 showed significant improvement: 42% improvement in the study group vs. 12% improvement in the controls (p = 0.001 for both groups). Group-by-time interaction (Cohen's d) was significant after the first treatment session for Oxford score, right hip internal rotation range of motion, and cervical length in the PFFM group and for perineometry and right hip internal rotation at the end of the study. ConclusionsBased on this pilot randomized trial, PFFM may potentially and partially 1. Alleviate symptoms, 2. Improve pelvic floor function and strength, and 3. Elongate the cervix after one or two treatment sessions. Further, a more extensive study is needed to confirm these results.

Faecal Microbiota Transplantation Engraftment After Budesonide or Placebo in Patients With Active Ulcerative Colitis Using Pre-selected Donors: A Randomized Pilot Study.

Faecal microbiota transplantation [FMT] shows some efficacy in treating patients with ulcerative colitis [UC], although variability has been observed among donors and treatment regimens. We investigated the effect of FMT using rationally selected donors after pretreatment with budesonide or placebo in active UC. Patients ≥18 years old with mild to moderate active UC were randomly assigned to 3 weeks of budesonide [9 mg] or placebo followed by 4-weekly infusions of a donor faeces suspension. Two donors were selected based on microbiota composition, regulatory T cell induction and short-chain fatty acid production in mice. The primary endpoint was engraftment of donor microbiota after FMT. In addition, clinical efficacy was assessed. In total, 24 patients were enrolled. Pretreatment with budesonide did not increase donor microbiota engraftment [p = 0.56] nor clinical response, and engraftment was not associated with clinical response. At week 14, 10/24 [42%] patients achieved [partial] remission. Remarkably, patients treated with FMT suspensions from one donor were associated with clinical response [80% of responders, p < 0.05] but had lower overall engraftment of donor microbiota. Furthermore, differences in the taxonomic composition of the donors and the engraftment of certain taxa were associated with clinical response. In this small study, pretreatment with budesonide did not significantly influence engraftment or clinical response after FMT. However, clinical response appeared to be donor-dependent. Response to FMT may be related to transfer of specific strains instead of overall engraftment, demonstrating the need to characterize mechanisms of actions of strains that maximize therapeutic benefit in UC.

Effects of Pain Neuroscience Education and Physiotherapy on Chronic Low Back Pain, Fear of Movement and Functional Status: A Randomised Pilot Study.

Background: Chronic non-specific low back pain is a non-harmous condition often found in the general population. It is one of the most significant disabilities and needs different treatment modalities. This study investigates the effects of pain neuroscience education and physiotherapy on pain intensity, fear of movement and functional status in a Lithuanian cohort with non-specific low back pain. Methods: The study was performed at the primary health care unit in Kaunas, Lithuania. The key inclusion criterion was persistent non-specific low back pain longer than three months and which affects daily life functions. Thirty participants (mean 33.47, SD 4.38 years age, 70% women) were randomised into two training groups with and without pain neuroscience education (for a total of 60 min of teaching). Physiotherapy was performed twice per week during 45 min/session for a period of 10 weeks with exercises which strengthen, stabilize, and stretch the spinal cord muscles. Outcomes included pain intensity, kinesiophobia and disability and these were measured by self-scored questionnaires (numeric rating scale, Tampa scale for kinesiophobia-11, Oswestry disability index and the Roland-Morris questionnaire, respectively). Results: The results indicate that both groups improved in the measured outcomes, with the only difference between them being a better improvement in kinesiophobia in the group receiving physiotherapy and pain neuroscience education. Conclusions: The results of this study confirm that a relatively short intervention of pain neuroscience education enhances the effects of physiotherapy and should be implemented in clinical practice.

Outcomes of Video-assisted Thoracic Surgery-guided Early Evacuation of Traumatic Hemothorax: A Randomized Pilot Study at Level I Trauma Center.

Traumatic hemothorax is accounted for about 20% of traumatic chest injuries. Although majority can be managed with the timely placement of intercostal tube (ICT) drainage, the remaining pose a challenge owing to high complication rates associated with retained hemothorax. Although various treatment modalities including intrapleural instillation of fibrinolytics, radioimage guided drainage, VATS guided evacuation and thoractomy do exist to address the retained hemothorax, but indications along with timing to employ a specific treatment option is still unclear and ambiguous. Patient with residual hemothorax (>200 mL) on ultrasonography after 48 h of indwelling ICT was randomized into either early video-assisted thoracic surgery (VATS) or conventional approach cohort. Early VATS cohort was subjected to video-assisted thoracoscopic evacuation of undrained blood along with normal saline irrigation and ICT placement. The conventional cohort underwent intrapleural thrombolytic instillation for 3 consecutive days. The outcome measures were the duration of indwelling ICT, removal rate of tube thoracostomy, length of hospital stay, duration of intensive care unit (ICU) monitoring, need for mechanical ventilation, incidence of pulmonary and pleural complications, and requirement of additional intervention to address undrained hemothorax and mortality rate. The early VATS cohort had shorter length of hospital stay (7.50 ± 0.85 vs. 9.50 ± 3.03, P = 0.060), reduced duration of indwelling ICT (6.70 ± 1.25 vs. 8.30 ± 2.91, P = 0.127) with higher rate of tube thoracostomy removal (70% vs. 30%, P = 0.003) and lesser need of additional interventions (0% vs. 30%, P = 0.105). Thoracotomy (3 patients) and image-guided drainage (4 patients) were additional interventions to address retained hemothorax in the conventional cohort. However, similar length of ventilator assistance (0.7 ± 0.48 vs. 0.60 ± 1.08, P = 0.791) and prolonged ICU monitoring (1.30 ± 1.06 vs. 0.90 ± 1.45, P = 0.490) was observed in early VATS cohort. Both the cohorts had no mortality. VATS-guided early evacuation of traumatic hemothorax is associated with shorter length of hospital stay along with abbreviated indwelling ICT duration, reduced incidence of complications, lesser readmissions, and improved rate of tube thoracostomy removal. However, the duration of ventilator requirement, ICU stay, and mortality remain unchanged.

Effect of a single small volume fluid bolus with balanced or un-balanced fluids on chloride and acid-base status: a prospective randomized pilot study (the FLURES-trial).

To compare the short-term effects on acid base, electrolyte status and urine output of a single fluid bolus of saline to that of the balanced solution Plasmalyte® in critically ill patients. Prospective, randomized, controlled trial. Adult patients (≥ 18years) admitted to the ICU receiving a fluid bolus were randomized to receive 1 L of saline (NaCl 0.9%, Baxter) or a balanced fluid [Plasmalyte® (Baxter)]. Blood samples and urine output were collected just before (T0), just after (T1), 2 h after (T2) (only for urinary output) and three hours after termination of the fluid bolus (T4). The effect of fluid boluses on serum chloride, apparent strong ion difference, base excess, urinary output and blood pressure or vasopressor need were analyzed. Patients who received a 1 L saline fluid bolus had a significant increase in serum chloride (1.60; 95% CI 1.10 to 2.10; P < 0.001) and short-term decrease in apparent strong ion difference (-1.85; 95% CI -2.71 to -0.99; P < 0.001) and base excess (-0.90; 95% CI -1.31 to -0.50; P < 0.001). We observed a 17% increase in patients developing hyperchloremia in the saline group (0.17; 95% CI 0.05 to 0.29; P = 0.005). No significant difference in urinary output, blood pressure or vasopressor need was observed in either group. Even a single, small bolus of saline, administered to critically ill patients, causes a significant increase in chloride concentration and a decrease in apparent strong ion difference and base excess, and an increase in the number of patients developing hyperchloremia. No difference in effect on urinary output, blood pressure or vasopressor need was observed between the two groups. 2014-001005-41; date of registration: 28/10/2014. EC project number 2014/038.

Erector spinae plane block as a component of intensive care for acute pancreatitis: a prospective randomized pilot study

BACKGROUND: Analgesia is crucial in the treatment of patients with acute pancreatitis, which includes the increased use of regional analgesia. In recent years, less-invasive and safer methods of pain relief, particularly erector spinae plane block (ESP-block), has drawn attention from the anesthesiological community. However, studies on its use in acute pancreatitis are rare. OBJECTIVE: Our aim was to make a clinical evaluation of bilateral erector spinae plane block in patients with acute pancreatitis. MATERIALS AND METHODS: A pilot prospective randomized study was conducted. The patients were divided into two groups: group 1 (n=7), ESP blockade was used, and group 2 (n=12), epidural analgesia (EA) was used. The primary points were considered to be an assessment of pain syndrome intensity and the need for analgesics. Additional results were liver and kidney function, acid-base condition, inflammatory response level, and the time of onset of peristalsis. RESULTS: The decrease in pain intensity in both groups was unidirectional: after 8 h, it was 3.57±1.98 points to the NRS in group 1 and 2.91±1.97 points to the NRS in group 2, and after 24 h, it was 1.42±1.27 and 1.75±2.3 points to the NRS, respectively. No significant difference was found in pain intensity between the groups (р 0,05). The average consumption of ketorolac was 78.2±16.3 mg in group 2 — 63.28±17.23 mg for 1 patient. The average need for narcotic analgesics, that is, morphine, per patient was 22±8 mg in group 1 and 36.3±17.2 mg in group 2 (р 0,05). During the therapy, blood α-amylase, diuresis rate, creatinine level, and glomerular filtration rate did not have a significant difference between the groups, as well as pH, BE, and blood lactate levels (р 0,05). Peristalsis was noted after 12.49±19.73 h in the ESP-block group and after 16.9±21.3 h in the 2nd group (р 0,05). The ICU length of stay between the groups did not differ and was 62±3 and 62±7 h, respectively (р 0,05). CONCLUSION: Bilateral erector spinae plane block is a simple and safe method that induces analgesic effect and effect on homeostasis in acute pancreatitis, similar to epidural blockade. Further study of the role and location of erector spinae plane block in treating pain in acute pancreatitis is required.

Differences in prescribing errors between electronic prescribing and traditional prescribing among medical students: A randomized pilot study.

This randomized controlled pilot study aimed to assess the differences in the frequency, type and severity of prescribing errors made by medical students when assessed in an electronic (e-)prescribing system compared to a traditional prescribing method (e.g., typing out a prescription). Fourth year medical students in the period of 1 November to 31 July 2023, were asked to participate in this single-centre prospective, randomized, controlled intervention study. Participants performed a prescribing assessment in either an e-prescribing system (intervention group) or in a more traditional prescribing platform (control group). The prescriptions were checked for errors, graded and categorized. Differences in prescribing errors, error categories and severity were analysed. Out of 334 students, 84 participated in the study. Nearly all participants (98.8%) made 1 or more prescribing errors, primarily involving inadequate information errors. In the intervention group, more participants made prescribing errors involving the prescribed amount (71.4 vs. 19.0%; P< .01), but fewer involving administrative errors (2.4 vs. 19.0%; P= .03). Prescribing-method-specific errors were identified in 4.8 and 40.5% of the intervention and control group, respectively, with significant differences in overlapping errors as well. This pilot study shows the importance of training e-prescribing competencies in medical curricula, in addition to traditional prescribing methods. It identifies prescribing-method-specific prescribing errors and emphasizes the need for further research to define e-prescribing competencies. Additionally, the need for an accessible real-life-like e-prescribing environment tailored to educators and students is essential for effective learning and incorporation of e-prescribing into medical curricula.

The feasibility and effect of robot-assisted gait training frequency on gait functions in children with cerebral palsy – A single blinded, randomized pilot study

Introduction. The aim of this study is to investigate the feasibility and the effect of Robot-assisted gait training (RAGT) frequency on gait functions in children with diplegic cerebral palsy (CP). We hypothesized that RAGT with the increased frequency (4 times a week) will result in greater improvements than RAGT with the common frequency (2 times a week). Material and methods. Fourteen participants with diplegic CP were assigned to two groups that received only RAGT at different frequencies. The treatment group (TG) received 24 sessions while the control group (CG) received only 12 sessions over 6 weeks. Gross motor function measure (GMFM) D, GMFM E, walking distance (6 minute-walk test), speed (10 meter-walk test), balance (Pediatric balance scale), and the quality of gait (Edinburgh visual gait score) were assessed. Data was collected twice, before and after RAGT intervention period. Also, the feasibility was assessed by the safety and the rates of recruitment, compliance, and adherence. Result. There was significant improvement in GMFM D, GMFM E, walking distance, balance, and the quality of gait in both groups (p &lt; 0.05). Walking speed has been significantly improved only in TG. The difference in the quality of gait is greater in TG (p &lt; 0.01) compared to CG (p &lt; 0.05). The recruitment rate was 70%. 100% of recruited participants complied with and adhered to the intervention. No adverse events were reported. Conclusion. RAGT with the increased frequency could induce greater improvement in gait functions than RAGT with the common frequency in children with diplegic CP.

Abstract 2246: The impact of a waitlist control group on physical activity level in the activity after cancer treatment exercise oncology randomized pilot study

Abstract Background: In randomized clinical trials, control conditions such as blinding are essential for mitigating threats to validity. In exercise oncology trials, researchers are unable to blind participants to randomization, which may confer unintended consequences (i.e., crossover or dropout) that may threaten validity. Despite prior suggestions that a waitlist control is optimal for lessening these consequences, to date there is little agreement concerning control conditions in exercise oncology. Further, the use of a waitlist control is complicated by concerns regarding the ethical implications of instructing participants to delay healthy behavior change. Herein, we leveraged data from the Activity after Cancer Treatment (ACT) study to evaluate the impact of randomization to a waitlist control group on objectively assessed physical activity (PA) levels in breast cancer (BC) survivors. Methods: The ACT Study (PI: Ambrosone) was a 12-week, four-arm pilot study at Roswell Park Comprehensive Cancer Center. Participants included 37 BC survivors who were randomized to either a waitlist control group (n=10), or one of three exercise interventions of varying intensities including home-based walking (n=9), home-based Zumba (n=9), or a supervised high-intensity interval training treadmill protocol (n=9) delivered by study personnel at Roswell Park Comprehensive Cancer Center. The waitlist group was asked to maintain their usual PA during the 12-week intervention. All participants received weekly phone calls to optimize engagement and ensure Fitbit data were properly synced. For the current analysis, the primary analytic exposure was randomization assignment (control or active intervention); the analytic outcomes included steps/day, moderate-to-vigorous PA (MVPA) minutes/week and total active minutes/week as measured by the Fitbit Charge 2. ANOVA was used to assess mean group differences in steps and active minutes. Results: At study conclusion, the control group accumulated significantly fewer steps/day [6,087 (±1,353)] than the active intervention groups [8,729 (±2,585), p=0.0003]. The control group also accumulated significantly fewer MVPA minutes/week [146.2 (±114.9) vs. 264.1 (±192.3), p=0.045] and total active minutes/week [1,478 (±291.0) vs. 1,976.8 (±658.6), p=0.003] in comparison to the active intervention groups, respectively. Conclusions: BC survivors randomized to active intervention accumulated significantly more steps, MVPA and total active minutes than the waitlist group. Although the waitlist was effective for minimizing PA relative to the active arms, waitlisted participants exceeded the national step average of 4800 steps/day by 1200 steps and nearly met the minimum PA recommendation of 150 minutes of MVPA/week, potentially assuaging ethical or public health concerns regarding the delay of health-seeking behavior. Citation Format: Rikki Cannioto, Evan Davis, Karen Hulme, Chi-Chen Hong, Carol DeNysschen, Tracey O'Connor, Christine Ambrosone. The impact of a waitlist control group on physical activity level in the activity after cancer treatment exercise oncology randomized pilot study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2246.