Primary Outcome Measure Research Articles

Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial

BackgroundOff-label intranasal administration of injectable dexmedetomidine has been widely applied in the pediatric sedation setting. However, the development of an improved drug delivery system that is easy to use is needed. We developed a novel dexmedetomidine nasal spray that can be administered directly without dilution or configuration for pediatric pre-anesthetic sedation. This nasal spray has a fixed dose and is stable during storage. To the best of our knowledge, this is the first licensed nasal spray preparation of dexmedetomidine worldwide.ObjectiveTo evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children.MethodsThe study was conducted at 11 sites in China between 24 November 2021 and 20 May 2022 and was registered in ClinicalTrials.gov (NCT05111431, first registration date: 20/10/2021). Subjects (n = 159) between 2 and 6 years old who were to undergo elective surgery were randomized to the dexmedetomidine group (n = 107) or the placebo group (n = 52) in a 2:1 ratio. The dosage was 30 µg or 50 µg based on the stratified body weight. The primary outcome measure was the proportion of subjects who achieved the desired child-parent separation and Ramsay scale ≥ 3 within 45 min of administration. Safety was monitored via the assessments of adverse events, blood pressure, heart rate, respiratory rate and blood oxygen saturation.ResultsThe proportion of subjects achieving desired parental separation and Ramsay scale ≥ 3 within 45 min was significantly higher in the dexmedetomidine group (94.4%) vs the placebo group (32.0%) (P < 0.0001). As compared with placebo, dexmedetomidine treatment led to more subjects achieving Ramsay scale ≥ 3 or UMSS ≥ 2, and shorter time to reach desired parental separation, Ramsay scale ≥ 3 and UMSS ≥ 2 (all P < 0.0001). Adverse events were reported in 90.7% and 84.0% of subjects in the dexmedetomidine and placebo groups, respectively, and all the events were mild or moderate in severity.ConclusionsThis novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile.

Cost-effectiveness of ace inhibitors versus ARBs in heart failure management.

Heart failure is a chronic condition that imposes a significant burden on healthcare systems worldwide. Effective management is crucial for improving patient outcomes and reducing costs. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are widely used to manage heart failure by reducing cardiac strain and preventing disease progression. Despite their common use, ACE inhibitors and ARBs differ in mechanisms, cost, and potential side effects. ACE inhibitors have long been the standard treatment, while ARBs are often prescribed to patients intolerant to ACE inhibitors, particularly due to side effects like cough. Given these differences, evaluating the cost-effectiveness of these treatments is essential. This study compares the cost-effectiveness of ACE inhibitors and ARBs from a healthcare system perspective, considering both direct medical costs and health outcomes. A cost-effectiveness analysis was conducted using a decision-analytic Markov model to simulate heart failure progression in a hypothetical cohort. Data inputs included clinical trial outcomes, real-world effectiveness data, direct medical costs (medications, hospitalizations, monitoring), and utility values for quality of life. The primary outcome measures were the cost per quality-adjusted life year gained and the incremental cost-effectiveness ratio. Sensitivity analyses tested the robustness of results, and subgroup analyses were conducted based on age and disease severity. The base-case analysis showed that ACE inhibitors were associated with lower overall costs and slightly higher quality-adjusted life years than ARBs. Sensitivity analyses revealed that variations in key parameters, such as transition probabilities, mortality rates, and healthcare expenses, had limited impact on the overall cost-effectiveness conclusions. Subgroup analyses indicated that ACE inhibitors and ARBs exhibited similar cost-effectiveness profiles for patients aged <65 and ≥65 years. However, among patients with severe heart failure, ARBs demonstrated a higher incremental cost-effectiveness ratio compared with ACE inhibitors, suggesting reduced cost-effectiveness in this subgroup. ACE inhibitors are likely a more cost-effective option for managing heart failure than ARBs, particularly from a healthcare system perspective. The findings underscore the importance of tailoring treatment decisions to individual patient factors, preferences, and clinical conditions, providing valuable insights for healthcare policy and practice, particularly regarding cost-effectiveness across patient subgroups.

Mobile phone call reminders to improve oral rehydration salt and zinc adherence for acute diarrhea in children: a single-center, randomized controlled trial

BackgroundLow-osmolarity oral rehydration salt (ORS) and zinc therapy effectively manage diarrhea in children under five years of age, offering both short- and long-term benefits. Despite this, caregivers’ adherence to ORS and zinc is often unsatisfactory due to factors such as forgetfulness, resolution of symptoms, and underestimation of the disease’s severity. This study assessed the effect of mobile call reminders on ORS and zinc tablet adherence among children with acute diarrhea in a secondary-level health facility in Kwara State, Nigeria.MethodsUsing an open-label, randomized controlled trial design, this study compared caregiver-child pairs with acute diarrhea aged 6–59 months who received standard instructions (SI) alone (control group) and an intervention group (IG) who received SI plus phone call reminders on days three and seven of zinc sulfate therapy. All participants used a pictorial diary to track loose/watery stools and ORS and zinc tablet treatments for ten days. The primary outcome measures were independent and combined adherence to ORS and zinc therapy. The secondary outcomes were independent and combined adherence scores, defined as the percentage of times the ORS was given post-diarrhea and the percentage of prescribed zinc tablets administered out of ten.ResultsA total of 364/400 mother–child pairs completed the study. The percentage of mothers with full adherence in the intervention group was 82.5% for ORS, 72.1% for zinc, and 58.5% for combined use, compared to 78.8%, 60.8%, and 43.6%, respectively, in the control group. The odds of full adherence to ORS and zinc were 1.6 and 1.7 times higher among intervention mothers [ORS: OR = 1.561, 95% CI = 0.939–2.598, P = 0.085; zinc: OR = 1.671, 95% CI = 1.076–2.593, P = 0.022], and 1.8 times higher for combined use according to WHO guidelines [OR = 1.818, 95% CI = 1.200–2.754, P = 0.005]. The mean adherence scores for the intervention group were higher than those for the control group by 4.1% (95% CI = 0.60–7.60) for ORS, 7.3% (95% CI = 3.74–10.86) for zinc, and 5.7% (95% CI = 3.23–8.17) for the combined treatment.ConclusionPhone reminders can effectively improve consistency of home treatment administered by caregivers for children under five years old.Trial RegistrationThe study was registered retrospectively (17/3/2023) with the Pan African Clinical Trial Registry (PACTR202301560735856).

Pain neuroscience education is not superior to spinal physiology and ergonomics education within a short multidisciplinary rehabilitation program: A randomized controlled trial

IntroductionThere is little evidence to suggest that one educational intervention is superior to another when associated with a rehabilitation program in the management of persistent low back pain. The objective of the present study was to compare pain neuroscience education with spine physiology and ergonomics education as part of a one-week multidisciplinary rehabilitation program. MethodWe conducted a randomized, controlled trial among patients having experienced persistent low back pain for at least 1 year. The patients participated in a one-week multidisciplinary rehabilitation program with an educational component. The members of the experimental and control groups received pain neuroscience education and spine physiology and ergonomics education, respectively. Outcomes were assessed before the program (day 0), immediately afterwards (day 5), and on day 90 after the start of the program. The primary outcome measure was functional disability on day 90. ResultsA total of 88 patients were randomized. On day 90, a statistically significant mean [95% confidence interval] decrease in the level of disability was observed in the experimental (PNE) group (−3.4 [-5.0 to −1.8]). The mean [95%CI] difference versus the control group (−1.7 [-4.0 to 0.5]) was not statistically significant (p = 0.12). There were no statistically significant intergroup differences in the secondary outcome measures. ConclusionThere appears to be no advantage in replacing a conventional, non-neuroscientific educational program (based on spinal physiology and ergonomics) with a pain neuroscience education program as part of a one-week multidisciplinary rehabilitation program. Further research is needed to identify patients who will respond better to a pain neuroscience education module as part of a personalized care program.

High serum progesterone levels on the day of embryo transfer in patients undergoing artificial frozen-thawed blastocyst transfer: Is there a ceiling effect?

To evaluate the potential ceiling effect of high serum progesterone levels on the day of embryo transfer for pregnancy outcomes in patients undergoing artificial frozen-thawed blastocyst transfer (FET) cycles. This retrospective cohort study included 595 patients who underwent artificial FET cycles. We evaluated progesterone levels and found that 40.6 ng/mL corresponded to the 90th percentile and 23.9 ng/mL corresponded to the 50th percentile. Based on these findings, we categorized progesterone levels as <20 ng/mL (n=220, 37.0%), 20-40 ng/mL (n=312, 52.4%), and ≥40 ng/mL (n=63, 10.6%). The primary outcome measures were the clinical pregnancy rate (CPR) and live birth rate (LBR). Blastocyst morphology grades, including expansion, trophectoderm, and inner cell mass grades, were significantly associated with clinical pregnancy (p<0.001 for all). Progesterone levels between 20 and 40 ng/mL were associated with higher CPR (p=0.043). In the multivariate analysis, only blastocyst expansion and inner cell mass grades were independently and significantly associated with CPR [p=0.011, odds ratio (OR)=1.6, (confidence interval) CI 95%=1.13-2.39, and p=0.007, OR=1.65, CI 95%=1.14-2.39, respectively]. The progesterone level and trophectoderm grade were not statistically significant. Regarding LBR, only blastocyst expansion grades 4 and trophectoderm grades A or B were significantly associated. Based on these data, we speculate that if serum progesterone levels exceed 40 ng/mL on the day of embryo transfer in patients undergoing artificial FET cycles, there is no need to reduce the progesterone dose.

Postoperative physical rehabilitation in the elderly patient after emergency surgery. Influence on functional, cognitive and quality of live recovery: study protocol for a randomized clinical trial

BackgroundThe progressive aging of the population has meant the increase in elderly patients requiring an urgent surgery. Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery. These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health.We aim to determine whether postoperative physical rehabilitation can prevent functional and cognitive decline and modify the posterior trajectory.Methods/designThis study is a randomized clinical trial, simple blinded, conducted in the Department of Surgery of a tertiary public hospital in Navarra (Hospital Universitario de Navarra), Spain. Patients > = 70 years old undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent physical training programme, which will include progressive and supervised endurance, resistance and balance training for 4 weeks, twice weekly sessions with a total of 8 sessions, and the group control will receive the usual care. The primary outcome measure is the change in functional (SPPB) and cognitive status (Mini-Mental State Examination) and the change of quality of life (EuroQol-5D-VAS) during the study period. The secondary outcomes are postoperative complications, length of stay, delirium, mortality, use of health resources, functional status (Barthel Index and handgrip strength tests), cost per quality-adjusted life year and mininutritional assessment. The data for both the intervention group and the control group will be obtained at four different times: the initial visit during hospital admission and at months 1, 3 and 6 months after hospital discharge.DiscussionIf our hypothesis is correct, this project could show that individualized and progressive exercise programme provides effective therapy for improving the functional capacity and achieve a better functional, cognitive and quality of life recovery. This measure, without entailing a significant expense for the administration, probably has an important repercussion both in the short- and long-term recovery, improving care and functional parameters and could determine a lower subsequent need for health resources. To verify this, we will carry out a cost-effectiveness study.The clinical impact of this trial can be significant if we help to modify the traditional management of the elderly patients from an illness model to a more person-centred and functionally oriented perspective. Moreover, the prescription of individualized exercise can be routinely included in the clinical practice of these patients.Trial registrationClinicalTrials.gov Identifier: NCT05290532. Version 1. Registered on March 13, 2022.

Elective hand surgery and concomitant corticosteroid injection: Confirming increased infection risk using A national dataset

BackgroundRecent studies demonstrate a link between corticosteroid injection and surgical complications when procedures occur shortly after steroid administration. These publications focus on single procedures like carpal tunnel release. This study seeks to demonstrate how surgical site infection risk changes across thirteen common elective hand procedures when steroid injection is performed contemporaneously. MethodsThe Truven MarketScan® database identified patients who had undergone elective hand surgery between 2015 and 2016. Two cohorts were created based on the administration, or absence thereof, of contemporaneous corticosteroid injection. The primary outcome measure was infection within 30 days of surgery as measured by antibiotic prescription or repeat surgical intervention. Multivariate logistic regression was performed to assess the association between concomitant corticosteroid injections and post-operative infections while controlling for demographics and comorbidities. Results149,689 patients underwent elective hand surgery. 6104 (4.1 %) received concomitant corticosteroid injection and 14,070 (9.4 %) received post-operative antibiotics or underwent secondary surgical intervention for infection. Treatment for post-operative infection was significantly higher in the corticosteroid group (10.2 % versus 9.3 %; p = 0.02) driven by difference in severe infection requiring surgical intervention (3.7 % versus 3.1 %; p = 0.03). This finding persisted when controlling for demographics and comorbidities with adjusted OR of 1.10 (CI 1.01–1.20) for all infections and 1.16 (CI 1.01–1.33) for severe infections. DiscussionThese results support prior findings that patients undergoing concurrent steroid injections and surgery have increased rates of infectious complications though the absolute risk remains small. Limitations of the database preclude further investigation into the details of each procedure (e.g. ipsilateral vs contralateral injection, peri-operative antibiotics) which may impact infection rates. ConclusionsConcomitant steroid injection with elective hand surgery may increase the risk of postoperative infection, particularly severe infection. However, that relative increase lies between 1 and 33 percent and should be weighed against the benefit from intraoperative corticosteroid administration.

Comparing efficacies of various papain-based enzyme agents and 2.4% sodium hypochlorite gel in chemomechanical caries removal: a randomized controlled trial

ObjectiveThis study aimed to evaluate and compare the efficacies of Papacarie Duo gel, Brix 3000, Selecti-Solve gel, 2.4% sodium hypochlorite gel, and conventional rotary-mechanical method in caries removal and to evaluate the patient comfort.MethodsIt was a single-blinded, randomized, parallel-group, active-controlled trial with five arms. It was conducted at the Department of Restorative Dentistry and Endodontics, Damascus University. Seventy-five specimens were randomly allocated into five groups: chemomechanical caries removal (CMCR) using Selecti-Solve gel (G1), BRIX3000 (G2), Papacarie DUO gel (G3), or 2.4% sodium hypochlorite gel (G4), and caries excavation using conventional rotary-mechanical method (G5) (control group). The trial considered healthy patients aged 18–40. Permanent molars with class I carious lesions extending to the middle third of dentin with no pulpal and/or periodontal pathology were included. The efficacy of caries removal was considered the primary outcome measure, and the secondary outcome measures were treatment time, volumetric measurement of the cavity, and pain assessment.ResultsThe majority (73.30%) of cases from BRIX3000 and conventional rotary-mechanical method groups showed complete caries removal (p = 0.982). The mean time of caries removal was the highest (17.45 ± 4.42) in the 2.4% sodium hypochlorite gel group (p < 0.05), and the lowest (6.33 ± 1.69) was in the conventional rotary-mechanical method group (p < 0.05). The mean cavity volume was the highest (18.97 ± 9.76) in the Papacarie DUO gel group, and the lowest (14.87 ± 4.76) was in the 2.4% sodium hypochlorite gel group (p = 0.506). The conventional rotary-mechanical group exhibited the highest mean score (5.40 ± 1.72) of pain (p < 0.05). However, the mean score (2.67 ± 1.11) of pain reported reduced in the BRIX3000 group.ConclusionsCMCR agents could be a potential substitute for conventional rotary instrumentation methods, taking into account the long working time.

Place of telemedicine in the organization of emergency care: feasibility and benefits

IntroductionTelemedicine encompasses all medical practices that allow patients to be remotely cared for through new information and communication technologies. This study aims to assess the remote management of patients consulting emergency services and not requiring in-hospital care during both pre-pandemic and pandemic periods of COVID-19.MethodsThis was a prospective, randomized, controlled study. The telemedicine group received follow-up at home after emergency room discharge according to a predefined protocol, with telephone calls on days 2, 7, 15, and 30. The control group received standard care without regular telephone follow-up (only a call on day 30). The study was conducted with patients consulting the emergency department of FarhatHached Hospital in Sousse. Patient inclusion occurred between November 1, 2019, and April 30, 2020. The primary outcome measures were the re-consultation rate and treatment adherence. The secondary outcome measure was patient satisfaction.SPSS version 23.0 for Windows was used for data analysis. Descriptive statistics calculated frequencies, percentages, means, standard deviations, medians, and range. Analytical study involved Student’s t-test and Pearson chi-square test for mean and frequency comparisons, respectively. Significance threshold (p) for all tests was set at 0.05.ResultsA total of 400 patients were included. The average age of patients was 40 years. Both groups were comparable in terms of demographics and clinical characteristics. Diagnoses included mainly benign infectious diseases, trauma, mild decompensations of chronic conditions (asthma, COPD, heart failure), and suspected COVID cases. Patients in the telemedicine group tended to reconsult less in the month following their initial emergency room visit (14% versus 26.5%) (p = 0.004). There was a significant difference in treatment adherence between the telemedicine group and the control group (97.5% versus 92%; p = 0.014). The satisfaction with telemedicine was higher than satisfaction with regard to an in-person consultation at the emergency department (90% versus 37.5%).ConclusionIt is necessary to implement telemedicine in Tunisia, especially in emergency services. It ensures better remote patient care by reducing re-consultation rates, increasing treatment adherence, and improving patient satisfaction.

Silencing siRNA microneedle patches versus silicone sheets in reducing post-surgical scars: a randomized single-blinded intra-individually controlled clinical trial.

A common complication of wounds is exuberant growth of fibrotic scar tissue, which can lead to hypertrophic scars or keloids. There are currently no treatments with good evidence for preventing excessive scar tissue formation. In this study, we explored the use of microneedle patches containing siRNA inhibiting SPARC mRNA in reducing the volume of post-surgical scars. We aim to compare the differences in the volume of post-surgical scars between daily application of siRNA-embedded dissolving microneedle patches and silicone sheets. The primary study outcome measure was the 3D volume of scar elevation.Our hypothesis was that scar formation in the half of the wound treated with siRNA microneedle patches will be lesser, as reflected by a smaller 3D volume, as compared to the half treated with silicone sheets. This was an 8-week, single-blinded intra-individually controlled randomised trial in a tertiary dermatological centre. Patients with two-week-old post-operative wounds were recruited. Each half of the scar was randomly assigned to the microneedle patch or silicone sheet. Three-dimensional (3D) volumes were obtained from the scars via a high-resolution scanner at day 0, 30 and 60. At day 30, scars treated with the microneedle patches had a lower geometric mean volume of 0.79mm3 when compared to scars treated with silicone sheets, with a difference in mean percentage volume reduction of 10.70%.At day 60, scars treated with the microneedle patches had a statistically significant lower volume (8.88mm3) when compared to the side treated with silicone sheets (12.77mm3, p=0.005), with a difference in mean percentage reduction of 9.66%. Additionally, there was also a statistically significant difference between the percentage reduction in scar volume, compared to baseline, on the side treated with microneedle patches (mean=83.78%) compared to the side treated with silicone sheets (mean=74.11%). There was a significantly greater reduction in the volume of post-surgical scars on the side treated with microneedle patches compared to the side treated with silicone sheets. This demonstrates the use of transdermal gene silencing technology for scar inhibition and that siRNA microneedle patches can be an effective and safe modality in the reduction of scar tissue formation. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12622000558729, https://www.anzctr.org.au.

Role of arterial blood glucose and interstitial fluid glucose difference in evaluating microcirculation and clinical prognosis of patients with septic shock: a prospective observational study

BackgroundMicrocirculation abnormality in septic shock is closely associated with organ dysfunction and mortality rate. It was hypothesized that the arterial blood glucose and interstitial fluid (ISF) glucose difference (GA−I) as a marker for assessing the microcirculation status can effectively evaluate the severity of microcirculation disturbance in patients with septic shock.MethodsThe present observational study enrolled patients with septic shock admitted to and treated in the intensive care unit (ICU) of a tertiary teaching hospital. The parameters reflecting organ and tissue perfusion, including lactic acid (Lac), skin mottling score, capillary refill time (CRT), venous-to-arterial carbon dioxide difference (Pv-aCO2), urine volume, central venous oxygen saturation (ScvO2) and GA−I of each enrolled patient were recorded at the time of enrollment (H0), H2, H4, H6, and H8. With ICU mortality as the primary outcome measure, the ICU mortality rate at any GA−I interval was analyzed.ResultsA total of 43 septic shock patients were included, with median sequential organ failure assessment (SOFA) scores of 10.5 (6–16), and median Acute Physiology and Chronic Health Evaluation (APACHAE) II scores of 25.7 (9–40), of whom 18 died during ICU stay. The GA−I levels were negative correlation with CRT (r = 0.369, P < 0.001), Lac (r = -0.269, P < 0.001), skin mottling score (r=-0.223, P < 0.001), and were positively associated with urine volume (r = 0.135, P < 0.05). The ICU mortality rate of patients with septic shock presenting GA−I ≤ 0.30 mmol/L and ≥ 2.14 mmol/L was significantly higher than that of patients with GA−I at 0.30–2.14 mmol/L [65.2% vs. 15.0%, odds ratio (OR) = 10.625, 95% confidence interval (CI): 2.355–47.503].ConclusionGA−I was correlated with microcirculation parameters, and with differences in survival. Future studies are needed to further explore the potential impact of GA−I on microcirculation and clinical prognosis of septic shock, and the bedside monitoring of GA−I may be beneficial for clinicians to identify high-risk patients.

Acupuncture-assisted therapy for prolonged disorders of consciousness: study protocol for a randomized, conventional-controlled, assessor-and-statistician-blinded trial.

Acupuncture is a promising non-pharmaceutical complementary therapy in treating prolonged Disorders of consciousness (pDOC), but solid evidence to support its effectiveness and safety is still lacking. Thus, the purpose of this study is to investigate the efficacy and safety of acupuncture-assisted therapy for pDOC patients. A single-center, prospective, randomized, conventional-controlled, assessor-and-statistician-blinded trial has been designed and is being conducted at West China Hospital of Sichuan University. A total of 110 participants will be randomly assigned to the experimental group and the control group in a 1:1 allocation ratio and evaluated using Coma Recovery Scale-Revised (CRS-R) at 8 a.m., 12 p.m., and 4 p.m. on 2 consecutive days before enrollment to determine the consciousness level. The experimental group will receive acupuncture combined with conventional treatment, while the control group will receive only conventional treatment during the trial observation period. The treatment duration of both groups will be 20 days. Among them, the frequency of acupuncture-assisted therapy is once a day, with 10 consecutive sessions followed by a day's rest for a total of 24 days. Data will be collected separately during baseline and after the final treatment. For data analysis, both Full Analysis Set (FAS) and Per Protocol Set (PPS) principles will be performed together by applying SPSS 27.0 software. The primary outcome measures are the changes of CRS-R before and after treatment, while the secondary outcome measures are the changes of Full Outline of Unresponsiveness Scale (FOUR), the changes of Nociception Coma Scale-Revised (NCS-R), the changes of Disability Rating Scale (DRS), the changes of Mismatch Negativity (MMN) and P300 before and after treatment, respectively. This trial aims to rationally assess the consciousness level from multiple 2 perspectives through subjective evaluation and objective detection by selecting several standardized clinical scales combined with Event-Related Potential (ERP) detection technology. In this way, we will be able to reduce the subjectivity of consciousness assessment and objectively evaluate the clinical efficacy of acupuncture-assisted therapy for pDOC. The study, if proven to be effective and safe enough, will provide a favorable evidence to guide medical decision-making choices and future researches. https://www.chictr.org.cn/, identifier ChiCTR2300076180.

Predictors of Chronic Dizziness in Acute Unilateral Vestibulopathy: A Longitudinal Prospective Cohort Study.

Chronic dizziness after acute unilateral vestibulopathy (AUVP) causes significant social and economic burdens. This study aims to identify predictors of chronic dizziness. Prospective, longitudinal cohort study. ENT departments from secondary and tertiary hospitals. Participants meeting the Barany Society's diagnostic criteria for AUVP were included. Evaluations occurred within 0 to 21 days (T1), and at 4 (T2) and 10 weeks (T3) postonset. The primary outcome measure was the Dizziness Handicap Inventory (DHI) at 6 months, with a score >30 indicating chronic dizziness. Five clusters of predictors were assessed at T1-3: central vestibular compensation, visual dependence, movement exposure, psychological factors, and balance performance. Separate linear regression models for T1, T2, and T3 were constructed to explain the variability in the 6-month DHI score. Receiver operating characteristics analyses were conducted to predict chronic dizziness. From June 2021 to January 2024, 103 participants (55.2 ± 16.6 years old, 49 women) were included. The regression models explained the variability in the 6-month DHI score by 33.0% at T1, 47.6% at T2, and 64.0% at T3 (P < .001), including psychological factors (T1, T2, T3), visual dependence (T2, T3), and static balance performance (T3). Cutoff values for the Vestibular Activities Avoidance Instrument (23/54), Visual Vertigo Analog Scale (33.5/100), and Hospital Anxiety and Depression Scale-Anxiety (7.5/21) at 10 weeks postonset predicted chronic dizziness. Higher psychological burden, increased visual dependence, and poorer static balance performance were associated with chronic dizziness. Cutoff values were determined to identify individuals with AUVP at risk for chronic dizziness.

Intraocular Pressure-Lowering Effect of Intraocular Lens Refixation in Patients with Elevated Intraocular Pressure Due to Intraocular Lens Subluxation

Background and Objectives: To evaluate the surgical outcomes of intraocular lens (IOL) refixation with vitrectomy in patients with elevated intraocular pressure (IOP) due to IOL subluxation. Materials and Methods: Patients with elevated IOP due to IOL subluxation who had undergone IOL refixation with vitrectomy between 1 June 2013 and 31 December 2023 were retrospectively evaluated. The primary outcome measure was surgical success or failure. Surgical success was defined as a reduction of ≥20% in the preoperative IOP or IOP ≤ 21 mmHg (criterion A), IOP ≤ 18 mmHg (criterion B), or IOP ≤ 15 mmHg (criterion C). Reoperation, loss of light perception, and hypotony were considered as surgical failure. The IOP, number of glaucoma medications used, postoperative complications, and visual acuity were evaluated as the secondary outcomes. The surgical outcomes were compared between the glaucoma and ocular hypertension (OH) groups. Results: At 12 months postoperatively, the probability of success was 72.5%, 54.1%, and 28.4% using criterion A, B, and C, respectively, and the mean IOP and mean number of glaucoma medications used had decreased significantly (p &lt; 0.01 and p = 0.03, respectively). Furthermore, the cumulative success rate was significantly higher in the OH group than in the glaucoma (100% vs. 47.4%; p &lt; 0.01) when using criterion A. Additional glaucoma surgery was required only in the glaucoma group. Conclusions: IOL refixation surgery significantly decreases the IOP and number of glaucoma medications required in patients with elevated IOP due to IOL subluxation. Thus, IOL refixation surgery alone without glaucoma surgery might be effective as the primary procedure in such patients.

Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT): study protocol for phase II two-centre, randomised controlled trial

IntroductionPhysical frailty is associated with increased mortality and poor quality of life (QoL) before and after liver transplantation (LT). Evidence is lacking on how to tailor exercise and behavioural techniques...

Treatment of Neuropsychiatric Symptoms in Parkinson's Disease With Botulinum Toxin A: A 12 week Randomized, Double-Blind, Placebo-Controlled Trial.

The study aimed to evaluate the impact of Botulinum toxin A (BoNT/A) on neuropsychiatric symptoms in Parkinson's disease (PD) patients. A total of 125 PD patients and an equal number of age- and gender-matched healthy controls were involved. Mental health status was assessed using the Cornell Medical Index (CMI) self-assessment questionnaire. Sixty-four PD patients exhibiting neuropsychiatric symptoms were selected for the controlled study and randomly grouped into treatment and control groups. The treatment group received BoNT/A injections, while the control group received a placebo. The primary outcome measures included depression scores from the CMI and the proportion of patients displaying improvement in neuropsychiatric symptoms at 8weeks post-treatment. The secondary outcome was other CMI scores at 4, 8, and 12weeks post-treatment. The outcomes revealed that PD patients had significantly higher scores in various neuropsychiatric factors compared to healthy controls. At 4weeks post-treatment, the treatment group displayed improvements in depression and tension. At 8 weeks post-treatment, they exhibited significant reductions in depression, anxiety, sensitivity, and tension compared to the control group. Moreover, a notably higher percentage of patients in the treatment group showed improvement in neuropsychiatric symptoms compared to the control group. At 12weeks post-treatment, the treatment group exhibited significant improvements in somatization, depression, sensitivity, and tension. PD patients commonly experience multiple neuropsychiatric symptoms, and BoNT/A has demonstrated efficacy in alleviating these symptoms. Specifically, BoNT/A was found to effectively alleviate somatization, tension, anxiety, depression, and sensitivity in PD patients.

Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy

Planning complex operations such as robotic-assisted laparoscopic radical prostatectomy (RALP) requires surgeons to review 2-dimensional magnetic resonance imaging (MRI) scans to understand 3-dimensional (3D) patient anatomy. Three-dimensional digital models for planning RALP may allow better understanding of patient anatomy and may lead to better patient outcomes, although data are currently limited. To determine surgical outcomes after RALP when surgeons reviewed 3D digital models during operative planning. This study was a planned secondary analysis of a multicenter, single-blind, randomized clinical trial conducted at 6 large teaching hospitals in the US. The study was conducted between January 1, 2019, and December 31, 2022, and included patients undergoing RALP. Patients were assessed and recruited at the time of surgical consultation. Final data analysis was conducted between August and December 2023. Patients were randomized to either a control group undergoing usual preoperative planning with prostate biopsy results and multiparametric MRI only or to an intervention group in which imaging and biopsy results were supplemented with a 3D digital model. This model was viewed on the surgeon's mobile phone in 3D format and picture-in-picture on the robotic console screen. The primary outcome measure for the overall study was oncologic outcomes after RALP, measured as prostate-specific antigen (PSA) detectability. Secondary outcomes were sexual function and urinary function, measured with Sexual Health Inventory for Men (SHIM) scores and rates of urinary incontinence, respectively, as well as use of salvage or adjuvant radiation therapy (RT) or androgen deprivation therapy (ADT). Trifecta outcomes were defined as undetectable PSA without RT or ADT, SHIM score categorically the same or greater than preoperatively, and complete continence. Univariate analysis was performed to compare outcomes between groups. This trial included 92 patients undergoing RALP (51 in the control group and 41 in the intervention group). Their mean (SD) age was 62 (7.4) years; 10 patients (10.9%) were Black and 67 (72.8%) were White. At 18 months postsurgery, the intervention group had lower rates of biochemical recurrence (PSA level >0.1 ng/mL, 0 vs 7 [17.9%]; absolute difference, 17.9% [95% CI, 1.8% to 31.8%]; P = .01) and were significantly less likely to undergo adjuvant or salvage RT (1 [3.1%] vs 12 [31.6%]; absolute difference, 28.5% [95% CI, 10.1% to 46.7%]; P = .002) compared with the control group. Sexual function at 18 months postsurgery was significantly better in the intervention group (mean [SD] SHIM score, 16.8 [8.7] vs 9.8 [7.7]; absolute difference, 7.0 [95% CI, 2.6 to 11.4]; P = .002) and urinary function was unchanged (total continence, 22 [78.6%] vs 29 [80.6%]; absolute difference, 2.0% [95% CI, -17.9% to 21.9%]; P = .84) compared with the control group. Trifecta outcomes were achieved for 12 (48.0%) patients in the intervention group and 3 patients (10.0%) in the control group (absolute difference, 38.0% [95% CI, 14.4% to 61.6%]; P = .002). In this secondary analysis of a randomized clinical trial, patients whose surgical planning of RALP involved 3D digital models had better oncologic and functional outcomes. Further work should assess the effect of 3D models in a broader set of patients, physicians, and hospital settings. ClinicalTrials.gov Identifier: NCT03943368.

An Institutional Febrile Neutropenia Protocol Improved the Antibacterial Treatment and Encouraged the Development of a Computerized Clinical Decision Support System

We investigated the influence of a local guideline on the quality of febrile neutropenia (FN) management and the applicability of a computerized decision support system (CDSS) using real-life data. The study included 227 FN patients between April 2016 and January 2019. The primary outcome measure was the achievement of a 20% increase in the rate of appropriate empirical treatment of FN in bacteremic patients. The compatibility of the CDSS (the development of which was completed in November 2021) with local protocols was tested using standard patient scenarios and empirical antibiotic recommendations for bacteremic FN patients. In total, 91 patients were evaluated before (P1: between April 2016 and May 2017) and 136 after (P2: between May 2017 and January 2019) the guideline’s release (May 2017). The demographic characteristics were similar. Appropriate empirical antibacterial treatment was achieved in 58.3% of P1 and 88.1% of P2 patients (p = 0.006). The need for escalation of antibacterial treatment was significantly lower in P2 (49.5% vs. 35.3%; p = 0.03). In P2, the performance of the CDSS and consulting physicians was similar (CDSS 88.8% vs. physician 88.83%; p = 1) regarding appropriate empirical antibacterial treatment. The introduction of the local guideline improved the appropriateness of initial empirical treatment and reduced escalation rates in FN patients. The high rate of compliance of the CDSS with the local guideline-based decisions in P2 highlights the usefulness of the CDSS for these patients.

Pre-operative EQ-5D-5L is a strong predictor of meaningful improvement in quality of life following primary total knee arthroplasty.

Predicting which patients will get meaningful benefit from total knee arthroplasty remains a challenge. Our aim was to assess if pre-operative quality of life (EuroQol 5-Dimension, 5-Level instrument; EQ-5D-5L) can predict the likelihood of a patient achieving post-operative improvement in patient-reported outcome measures (PROMS) following total knee arthroplasty to a level of minimum clinically-important difference (MCID). This was a retrospective analysis of a prospective cohort of total knee arthroplasty patients. EQ-5D-5L and Oxford Knee Scores (OKS) were recorded pre-operatively, 6months and 2years post-operatively. The primary outcome measure was achievement of MCID in EQ-5D-5L at 2years. Multivariable analysis through multiple logistic regression was performed to assess for independent predictors of MCID in EQ-5D-5L, OKS and re-operation at 2years. 400 patients were included, with 57% female and a mean age of 66years. Pre-operative EQ-5D-5L was the only strong predictor of post-operative EQ-5D-5L MCID (OR: 0.016, CI: 0.004 to 0.06), when adjusted for age, gender, BMI, ASA, smoking status and surgeon grade. The optimal pre-operative EQ-5D-5L threshold was found to be 0.53 by Youden's index, with a sensitivity of 70% and specificity of 73%. Pre-operative quality of life as measured by EQ-5D-5L is a strong independent predictor of reaching MCID in EQ-5D-5L following total knee arthroplasty. Those with worse EQ-5D-5L are more likely to gain meaningful benefit from knee arthroplasty.

Efficacy of Closed-Incision Negative Pressure Wound Therapy in Reducing Postoperative Complications in Breast Reconstruction After Radiotherapy: A Propensity Score Analysis

Abstract Background Implant based breast reconstruction following radiotherapy can lead to significant post-operative complications. Closed-incision negative pressure wound therapy (ciNPWT) has emerged as a potential intervention to reduce these complications. Objectives To assess the effectiveness of closed-incision negative pressure wound therapy (ciNPWT) in reducing post-operative complications in patients undergoing implant-based breast reconstruction after radiotherapy. Methods A retrospective single-center cohort study was conducted, including patients who underwent implant-based breast reconstruction after mastectomy and radiotherapy between January 1, 2015, and December 31, 2022. We utilized a procedure-level analysis model with patients contributing distinct observations for multiple procedures. Our primary outcome measures included fluid collection, infection, and wound complications. Propensity score analysis was employed to adjust for potential confounders, such as BMI, smoking history, and diabetes history, creating a balanced comparison between the ciNPWT-treated and untreated groups. Results In our study of 301 breast reconstructions post-radiotherapy from 2015-2022, encompassing 218 unique patients, we found significant benefits of ciNPWT. During an average 2.2-year follow-up, the ciNPWT group demonstrated no infections, contrasting with a 10.4% rate in the non-ciNPWT group (p&amp;lt;0.0001). Wound complications were also significantly lower in the ciNPWT group (1.9% vs. 11.2%) (p=0.00848). Demographic differences were adjusted using inverse probability of treatment weights. The findings suggest ciNPWT's promising role in enhancing postoperative outcomes in breast reconstruction post-radiotherapy. Conclusions Our study suggests that the use of ciNPWT in implant-based breast reconstruction post- radiotherapy can potentially reduce postoperative complications. This intervention can improve patient outcomes and may offer cost-saving benefits in the long run.