Primary Outcome Measure Research Articles

Clinician and health service interventions to reduce the greenhouse gas emissions generated by healthcare: a systematic review

ObjectiveTo synthesise the available evidence on the effects of interventions designed to improve the delivery of healthcare that reduces the greenhouse gas (GHG) emissions of healthcare.DesignSystematic review and structured synthesis.Search...

High-frequency magnetic paired associated stimulation promotes motor function recovery in ischemic stroke patients: a study protocol for single-center, sham stimulation randomized controlled trials (H2MPAS)

BackgroundNumerous studies have validated the clinical effectiveness of electromagnetic pairing-associated stimulation. Building upon this foundation, we have developed a novel approach involving high-frequency magnetic paired-associated stimulation, aiming to enhance clinical applicability and potentially improve efficacy. However, the clinical effectiveness of this approach remains unclear. Our objective is to demonstrate the therapeutic efficacy of this novel approach by employing high-frequency pairing to intervene in patients experiencing motor dysfunction following a stroke.MethodsThis is a single-center, single-blind, sham stimulation controlled clinical trial involving patients with upper limb motor dysfunction post-stroke. The intervention utilizes paired magnetic stimulation, combining peripheral and central magnetic stimulation, in patients with Brunnstrom stage III–V stroke lasting from 3 months to 1 year. Evaluation of patients’ upper limb motor function occurred before the intervention and after 3 weeks of intervention. Follow-up visits will be conducted after 5 weeks and 3 months of intervention. The primary outcome measure is the Action Research Arm Test, with secondary measures including the Fugl-Meyer Assessment-upper, Modified Barthel Index, modified Tardieu scale, functional near-infrared spectroscopy, and neuroelectrophysiology.DiscussionThe high-frequency magnetic paired associative stimulation used in this study combined high-frequency magnetic stimulation with paired stimulation, potentially facilitating both cortical excitation through high-frequency stimulation and specific circuit enhancement through paired stimulation. As dual-coil magnetic stimulation equipment becomes increasingly popular, magnetic-magnetic paired associated stimulation may offer patients improved clinical outcomes at reduced costs.Trial registrationChinese Clinical Trial Registry,ChiCTR2400083363. Registered on 23 April 2024.

Functional outcome and quality of life index after endonasal versus external dacryocystorhinostomy

Abstract Purpose: To compare the functional outcome and quality of life (QOL) index following non-endoscopic endonasal dacryocystorhinostomy (NEN-DCR) and external dacryocystorhinostomy (EXT-DCR). Methods: Patients were prospectively allocated to two groups. All adult patients presenting with primary nasolacrimal duct obstruction (PANDO) undergoing EXT-DCR and NEN-DCR at a tertiary eye care center were included. Patients in one group underwent EXT-DCR and others NEN-DCR. Functional outcomes were measured by Munk Score and fluorescein dye disappearance test (FDDT). A validated quality of life questionnaire (EQ-5D-3L) in the local language (Odiya) was used to measure health status (social impact score) before and 1 day, 2 weeks, 6 weeks, and 3 months after surgery. The primary outcome measure was the functional outcome–Munk Score and secondary outcome measures included the QOL index and the FDDT. Results: A total of 110 patients were recruited and equally distributed (n = 55) in both groups. The mean age of the population was 47.6 years (SD = 14.02; range 20–79 years). The majority (71%, 79/110) were female. When longitudinally followed over time, functional outcome and QOL index showed reasonably rapid and marked improvement in both groups after surgery compared to baseline scores. The Munk score (P = 0.037) and QOL index (P = 0.007) were marginally better on the first postoperative day for the NEN-DCR group compared to EXT-DCR but comparable at all subsequent visits. At a median follow-up of 9 weeks (range: 0.5–24 weeks), the anatomical outcome was comparable between both groups. Conclusion: Our results demonstrate that functional outcome and QOL index show rapid and marked improvement in both NEN-DCR and EXT-DCR after surgery. NEN-DCR outcomes were marginally better on the first postoperative day but comparable to EXT-DCR thereafter.

The potential benefit of artificial intelligence regarding clinical decision-making in the treatment of wrist trauma patients

PurposeThe implementation of artificial intelligence (AI) in health care is gaining popularity. Many publications describe powerful AI-enabled algorithms. Yet there’s only scarce evidence for measurable value in terms of patient outcomes, clinical decision-making or socio-economic impact. Our aim was to investigate the significance of AI in the emergency treatment of wrist trauma patients.MethodTwo groups of physicians were confronted with twenty realistic cases of wrist trauma patients and had to find the correct diagnosis and provide a treatment recommendation. One group was assisted by an AI-enabled application which detects and localizes distal radius fractures (DRF) with near-to-perfect precision while the other group had no help. Primary outcome measurement was diagnostic accuracy. Secondary outcome measurements were required time, number of added CT scans and senior consultations, correctness of the treatment, subjective and objective stress levels.ResultsThe AI-supported group was able to make a diagnosis without support (no additional CT, no senior consultation) in significantly more of the cases than the control group (75% vs. 52%, p = 0.003). The AI-enhanced group detected DRF with superior sensitivity (1.00 vs. 0.96, p = 0.06) and specificity (0.99 vs. 0.93, p = 0.17), used significantly less additional CT scans to reach the correct diagnosis (14% vs. 28%, p = 0.02) and was subjectively significantly less stressed (p = 0.05).ConclusionThe results indicate that physicians can diagnose wrist trauma more accurately and faster when aided by an AI-tool that lessens the need for extra diagnostic procedures. The AI-tool also seems to lower physicians' stress levels while examining cases. We anticipate that these benefits will be amplified in larger studies as skepticism towards the new technology diminishes.

Elevated serum albumin-to-creatinine ratio as a protective factor on clinical outcomes among critically ill patients with sepsis: a retrospective study

BackgroundThe aim of this study was to examine the prognostic significance of serum albumin-to-creatinine ratio (ACR) in critically ill patients with sepsis.MethodsThis retrospective study analyzed sepsis cases admitted to the Affiliated Hospital of Jiangsu University between January 2015 and November 2023. The patients were divided into four groups based on their ACR upon admission to the intensive care unit (ICU). Laboratory data were collected at the time of ICU admission, and the primary outcome measure was in-hospital all-cause mortality. Kaplan–Meier survival curves were generated to illustrate the differences in 30−/60-day mortality among the various groups. Multivariate Cox regression models and restricted cubic splines (RCS) were utilized to explore the association between ACR and all-cause mortality in sepsis patients. Subgroup analyses were conducted to examine the impact of other covariates on the relationship between ACR and all-cause mortality.ResultsA total of 1,123 eligible patients were included in the study, with a median ACR of 0.169. The in-hospital mortality rate was 33.7%, the ICU mortality rate was 31.9%, and the 30-day mortality rate was 28.1%. Kaplan–Meier survival analysis demonstrated that patients with higher ACR had a significantly lower risk of 30−/60-day mortality (log-rank p < 0.001). Multivariable Cox proportional hazards analyses revealed that ACR was an independent predictor of in-hospital death (HR: 0.454, 95% CI 0.271–0.761, p = 0.003), ICU death (HR: 0.498, 95% CI 0.293–0.847, p = 0.010), and 30-day death (HR: 0.399, 95% CI 0.218–0.730, p = 0.003). For each 1-unit increase in ACR, there was a 1.203-fold decrease in the risk of death during the hospital stay. The RCS curve illustrated a non-linear negative correlation between ACR and in-hospital mortality (p for non-linear =0.018), ICU mortality (p for non-linear =0.005), and 30-day mortality (p for non-linear =0.006). Sensitivity analysis indicated consistent effect sizes and directions in different subgroups, confirming the stability of the results.ConclusionLow ACR levels were identified as independent risk factors associated with increased in-hospital, ICU, and 30-day mortality in sepsis patients. ACR can serve as a significant predictor of the clinical outcome of sepsis.

Evaluating diagnostic and management agreement between physiotherapists and ear, nose and throat specialist in a primary contact physiotherapy-led vestibular clinic: A prospective blinded inter-rater agreement pilot study

BackgroundDizziness and vertigo are common referrals to Ear Nose Throat (ENT) outpatient services however these services have long waitlists for assessment. Primary contact physiotherapy-led vestibular clinics are recognized as improving access to care. This pilot study investigated agreement between physiotherapists and an ENT medical practitioner for diagnostic and management decisions in patients attending a primary contact physiotherapy-led vestibular clinic.MethodsProspective blinded inter-rater agreement study undertaken in an ENT primary contact physiotherapy-led vestibular clinic. Participants were adults referred to ENT from general practitioners, triaged (Category 2 or 3) to the primary contact physiotherapy-led vestibular clinic with clinical symptoms consistent with vestibular disorder. Primary outcome measures included agreement of diagnoses and management decisions made by an ENT medical practitioner and Physiotherapist based on a vestibular physiotherapy assessment. Adverse events were reviewed 11 months post data collection. Gwet’s first order agreement co-efficient (AC1) calculated inter-rater reliability between physiotherapy and ENT.ResultsFifty-one participants were recruited consecutively from the primary contact physiotherapy-led vestibular clinic. Physiotherapy and ENT had a substantial agreement (AC1 0.613) on diagnosis. AC1 between physiotherapy and ENT for recommending Magnetic resonance imaging (0.810) and computerized tomography (0.935) both indicated near perfect agreement. There was moderate to near-perfect agreement regarding management recommendations between physiotherapy and ENT. Substantial agreement (AC1 0.720) was found for recommendations for ENT input, near perfect agreement (AC1 0.933) for neurology input and moderate agreement (AC1 0.574) for physiotherapy input. There were no adverse events from physiotherapist’s management decision, based on final recommendations undertaken 11-months post data collection.ConclusionsPhysiotherapists and ENT medical practitioner made comparable diagnostic and management decisions, based on physiotherapy and audiology hearing assessment, for adults with signs of vestibular dysfunction, within an ENT primary contact physiotherapy-led vestibular clinic. This study provides support for this type of Physiotherapy-led service in managing patients referred to an ENT service with vestibular dysfunction.

Child life specialists predict successful MRI scanning in unsedated children 4 to 12years old.

It can be challenging for children to cooperate for a magnetic resonance imaging (MRI) exam. General anesthesia is often used to ensure a high-quality image. When determining the need for general anesthesia, many institutions use a simple age cutoff. Decisions on the necessity for anesthesia are often left to schedulers who lack training on determination of patient compliance. The study aimed to evaluate whether screening questions administered by certified child life specialists (CCLS) could successfully predict which children could complete an MRI without sedation. This is a retrospective, institutional review board approved study. Data was collected as part of a quality improvement program, where a CCLS screened 4- to 12-year-old children scheduled for MRI scanning using a questionnaire. Parent responses to the screening questions, CCLS's recommendation for scheduling the MRI awake, start and end time for the MRI scan, and scan success were recorded. A predictive model for the CCLS's recommendation was developed using the child's age, estimated scan length, scan difficulty, and the parent's responses to the screening questions. The primary outcome measure was a successfully completed MRI not requiring additional imaging under anesthesia. Of the 403 screened children, 317 (79%) were recommended to attempt the MRI without anesthesia. The median age of participants was 7 (IQR 4-17) years. Overall, 309 of 317 (97.5%) participants, recommended by the CCLS for the program, met the primary outcome of successful MRI completion on their first attempt. The multivariable regression model which included clinical information about the child's age, estimated scan length, scan difficulty, and four of the six parent screening questions had excellent performance (area under the curve = 0.89). Information collected by the CCLS via screening along with the child's age, the estimated scan length, and difficulty can help predict which children are likely to successfully complete a non-sedate MRI.

Effectiveness of autologous mononuclear cells as adjuvant therapy in patients with ischaemic diabetic foot ulcers receiving indirect lower limb revascularization.

The current study aimed to evaluate the effectiveness of peripheral blood mononuclear cells (PB-MNCs) therapy for patients with ischaemic diabetic foot ulcers (DFUs) treated through indirect revascularization. The study is a prospective non-controlled observational study including patients with neuro-ischaemic DFUs who received indirect peripheral revascularization and showed a persistence of wound ischaemia defined by the absence of angiographic collateral vessels and TcPO2 values < 30mmHg in the wound angiosome area. All patients received 3 cycles of PB-MNCs therapy administered along the wound related artery based on the angiosome theory. The primary outcomes measures were healing, major amputation, and survival after 1year of follow-up. The secondary outcomes measures were the evaluation of tissue perfusion by TcPO2 and foot pain defined by the Numerical Rating Scale (NRS). Overall 52 (9.7%) patients were included. Most patients were aged (> 70years), all of them were affected by Type 2 Diabetes with a long diabetes duration (> 20years). Almost 80% were assessed as grade 2D- 3D of Texas University Classification. Forty-four patients (84.6%) patients healed and survived, 2 (3.85%) healed and deceased, 2 (3.85%) not healed and deceased, 4 (7.7%) not healed and survived. No major amputations were recorded. A significant increase of TcPO2 after PB-MNCs therapy were recorded in comparison to the baseline (43 ± 9 vs 18 ± 8mmHg, p < 0.0001), such asa concomitant reduction of foot pain (1.8 ± 1.2 vs 6.2 ± 2.1, p < 0.0001). PB-MNCs resulted effective to promote wound healing and limb salvage in diabetic patients with ischaemic DFUs who received indirect revascularization.

Comparison of the effects of acupuncture methods on the temporomandibular disorder: A network meta-analysis.

A network meta-analysis (NMA) was applied to compare the therapeutic effect of different acupuncture methods on temporomandibular disorder (TMD). A computer retrieval was carried out in the English databases of Cochrane, PubMed, Embase and Web of Science, as well as the Chinese databases of CNKI, Wanfang and VIP for randomized controlled trials on the effect of acupuncture on TMD, with a retrieval deadline of January 21, 2024. Data analysis was conducted using R software and Bayesian method. The pain score served as the primary outcome measure, with the mouth opening as the secondary outcome measure. Thirty-five articles were included in the analysis, involving 1937 TMD patients. The NMA results suggested that DN-PT had the best effect on relieving pain and improving mouth opening. (Description of all abbreviations in Supplementary Material S3). Based on the available evidence, the results of the NMA suggest that DN-PT is most effective in relieving TMD pain and increasing mouth opening. However, due to the fact that some acupuncture therapies are only reported in a small number of research reports, this may lead to an increase in the randomness of the results and a decrease in the reliability.

A study protocol for a randomized controlled trial on the effect of Surya Nadi Pranayama practice on cognitive abilities in school children

Abstract Background Surya Nadi Pranayama is a yogic breathing technique that involves controlled breathing through the right nostril. The study aims to evaluate the effects of the 20-min practice of Surya Nadi pranayama (4 weeks) on cognition among schoolchildren, comparing it to observing a normal breathing pattern. Methods A randomized control study design will be adopted for this study with 100 school children with 12–16 years of age, will be recruited. Subjects will be randomly divided into the study and control groups. The study group will be advised to practice Surya Nadi Pranayama (n = 50), whereas the control group (n = 50) will be asked to relax in a sitting posture between 9 am and 10 am, Monday to Friday, for 20 min daily over 30 days. Results A baseline and post-intervention assessment will be performed for all the subjects a day before and after the intervention. The primary outcome measures are visual reaction time and auditory reaction time. The secondary outcome is critical flicker fusion frequency. Conclusion The potential benefits of this yogic breathing technique and the findings of this research may contribute to the development of interventions aimed at improving cognitive functioning in school-aged children. The study is prospectively registered in the Clinical Trial Registry of India (CTRI/2024/05/067441).

Stepwise dual-target magnetic resonance-guided focused ultrasound in tremor-dominant Parkinson disease: One-year follow-up.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a nonsurgical treatment for Parkinson disease (PD). Some selected anatomical structures can be targeted by MRgFUS in PD. However, there is no uniform target yet. We have reported that stepwise dual-target MRgFUS was successfully applied to treat refractory tremors with akinetic-rigid features in PD. It generated two precise thermal ablations in the ventral intermediate nucleus (VIM) and pallidothalamic tract (PTT). Here, we report more PD patients to verify the safety and efficacy of stepwise dual-target MRgFUS. Ten tremor-dominant PD patients (mean age = 66.7 ± 3.2 years, eight men) received the stepwise dual-target MRgFUS treatment with a series of primary and secondary outcome measures. The VIM and PTT were navigated based on brain magnetic resonance images. Outcome measures were categorized into primary and secondary assessments. The primary outcome measures consisted of resting tremor, action/kinetic tremor, rigidity, and bradykinesia. Secondary outcome measures encompassed non-motor symptoms scale of PD. Data collected at follow-up time points, including 1 day, 3 months, 6 months, and 1 year posttreatment, were compared with baseline data. The severity of tremor and motor deficits represented by Clinical Rating Scale for Tremor parts A and B during off-medication status and Unified Parkinson's Disease Rating Scale III on the treated side were significantly improved (p < 0.05 by paired t-test) at 1-year follow-up. At the 1-year follow-up, significant improvement was observed in the non-motor symptoms scale. Additionally, no severe adverse effects were reported, except temporary treatment-related discomfort during the procedure. In conclusion, stepwise dual-target MRgFUS emerges as a safe and effective therapeutic modality for PD patients, particularly in addressing medication-refractory tremor and akinetic-rigid syndrome.

Endoscopic ultrasound-guided fine needle biopsy using macroscopic on-site evaluation technique reduces the number passes yet maintains a high diagnostic accuracy: A randomized study.

Although rapid on-site cytological evaluation (ROSE) for endoscopic ultrasound (EUS)-guided tissue acquisition (EUS-TA) may increase diagnostic yield, it is not widely available. Macroscopic on-site evaluation (MOSE) is an alternative modality although it is not standardized for EUS-guided fine-needle biopsy (FNB). We evaluated diagnostic performance of MOSE compared with conventional technique of EUS-TA using core biopsy needle. Consecutive patients undergoing EUS-FNA for solid lesions were randomized to MOSE or conventional arms. The primary and secondary outcome measures were diagnostic accuracy, diagnostic yield, sensitivity, specificity, positive and negative predictive values, and the number of passes, respectively. The optimum parameters for macroscopic visible core (MVC, i.e., length, number) by MOSE to achieve accurate diagnosis were evaluated. Ninety-six patients (48 conventional and 48 MOSE) were enrolled. Mean lesion size was larger in MOSE arm (32.67±7.22 vs 29.31±6.98mm, P=0.023). Diagnostic accuracy (95.8% vs 91.6%), diagnostic yield (97.9% vs 95.8%), procedure duration, and adverse events of the two methods were similar. Median number of passes with MOSE was less (2 vs 3 P=0.000). Area under the receiver operating characteristic curve showed that with MOSE, obtaining a total MVC length of 11.5mm had 93.3% sensitivity, and 2.5 MVC cores (each 4mm) had 86.7% sensitivity for malignancy diagnosis. EUS-FNB with MOSE, a simple reliable technique, can achieve a high and comparable diagnostic accuracy with lesser number of passes. Obtaining longer length and greater number of MVC increase the sensitivity to diagnose malignancy with MOSE.

A Suicide Prevention Digital Technology for Individuals Experiencing an Acute Suicide Crisis in Emergency Departments: Naturalistic Observational Study of Real-World Acceptability, Feasibility, and Safety.

Emergency departments (EDs) are the front line in providing suicide care. Expert consensus recommends the delivery of several suicide prevention evidence-based interventions for individuals with acute suicidal ideation in the ED. ED personnel demands and staff shortages compromise delivery and contribute to long wait times and unnecessary hospitalization. Digital technologies can play an important role in helping EDs deliver suicide care without placing further demands on the care team if their use is safe to patients in a routine care context. This study evaluates the safety and effectiveness of an evidence-based digital technology (Jaspr Health) designed for persons with acute suicidal ideation seeking psychiatric crisis ED services when used as part of routine ED-based suicide care. This study deployed Jaspr Health for real-world use in 2 large health care systems in the United States and aimed to evaluate (1) how and whether Jaspr Health could be safely and effectively used outside the context of a researcher-facilitated clinical trial, and (2) that Jaspr's use would be associated with improved patient agitation and distress. Under the auspices of a nonsignificant risk device study, ED patients with acute suicidal ideation (N=962) from 2 health care systems representing 10 EDs received access to Jaspr Health as part of their routine suicide care. Primary outcome measures included how many eligible patients were assigned Jaspr Health, which modules were assigned and completed, and finally, the number of adverse events reported by patients or by medical staff. Secondary outcome measures were patient agitation, distress, and satisfaction. The most frequent modules assigned were Comfort and Skills (98% of users; n=942) and lethal means assessment (90% of patient users; n=870). Patient task completion rates for all modules ranged from 51% to 79%. No adverse events were reported, suggesting that digital technologies can be safely used for people seeking ED-based psychiatric services. Statistically significant (P<.001) reductions in agitation and distress were reported after using the app. Average patient satisfaction ratings by site were 7.81 (SD 2.22) and 7.10 (SD 2.65), with 88.8% (n=325) and 84% (n=90) of patients recommending the app to others. Digital technologies such as Jaspr Health may be safely and effectively integrated into existing workflows to help deliver evidence-based suicide care in EDs. These findings hold promise for the use of digital technologies in delivering evidence-based care to other vulnerable populations in complex environments.

Study to determine the efficacy and onset of Bonipar, a topical analgesic for the management of acute and chronic musculoskeletal pain

BackgroundOpioid abuse and mortality are ravaging American society, highlighting the need to find alternative effective analgesics with fewer side effects. FDA-approved topical analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs), are commonly used to treat musculoskeletal pain but can cause adverse effects. Natural compounds, including essential oils, are potential therapeutic alternatives for managing musculoskeletal pain. If these compounds can provide comparable analgesia to FDA-approved products, it will increase the available options for people with pain, improving quality of life with minimal morbidity and mortality. ObjectiveThis study assesses the effectiveness and onset of action of Bonipar, a topical analgesic formulated with camphor, methyl salicylate, and oils of coconut, eucalyptus, nutmeg, and rosemary, in managing musculoskeletal pain compared to 1.5 % diclofenac solution, an FDA-approved topical non-steroidal anti-inflammatory drug. MethodsOne hundred sixty-four adult patients with localized musculoskeletal pain were randomly assigned to twice-daily applications of either Bonipar or Diclofenac for one week. The primary outcome measure was a 50 % reduction in pain after one week. Secondary outcomes included the change in pain from baseline and onset of action, defined as the first reduction in pain by 20 %. ResultsAll patients completed the initial pain assessment to determine the onset of action. One-week data was available for 74 patients treated with diclofenac and 72 patients treated with Bonipar. Data for 18 patients were incomplete. The proportion of patients achieving a 50 % reduction in pain was statistically similar between the two groups. The success rates of achieving a 50 % pain reduction with Bonipar were found to be non-inferior to those treated with diclofenac. All follow-up time points showed roughly similar results between the groups. Regression models adjusted for age and sex revealed no significant effects on pain changes. Secondary analyses demonstrated no significant differences between the groups. DiscussionThe topical analgesic Bonipar demonstrates a comparable onset of action, with efficacy non-inferior to diclofenac in the management of musculoskeletal pain, while showing fewer adverse effects compared to diclofenac. These findings highlight the potential of Bonipar as a valuable alternative for the treatment of localized pain.

Interventions for the prevention of weight gain during festive and holiday periods in children and adults: A systematic review.

Some periods during the year, such as festive and summer holiday periods, have been associated with weight gain. We aimed to assess the effect of interventions for the prevention of body weight gain during festive and holiday periods in children and adults. A systematic search was conducted in six databases and supplementary sources until January 4, 2023. We included randomized controlled trials (RCTs), cluster-RCTs, and non-RCTs. Our primary outcome measure was the change in body weight in adults or the change in BMI z-score or BMI percentile in children and adolescents. From 4216 records, 12 primary studies (from 22 reports) met the inclusion criteria-10 from the United States, one from the United Kingdom, and one from Chile. Two studies had a low risk of bias, two moderate, seven high, and one critical risk of bias. The meta-analysis in children included four of seven studies during the summer holidays (six interventions) and showed a mean difference in BMI z-score favoring the intervention group (-0.06 [95% CI -0.10, -0.01], p = 0.01, I2= 0%, very low certainty evidence). The meta-analysis in adults included five studies during festive periods with a mean difference in weight favoring the intervention group (-0.99 kg [95% CI -2.15, 0.18], p = 0.10, I2= 89%, very low certainty evidence). This review has highlighted potential interventions to prevent the increase in body weight during holiday periods. More work is needed to improve the quality of the evidence and to extend it to countries outside of the United States and United Kingdom and to the adolescent population.

Effects of dietary interventions for metabolic acidosis in chronic kidney disease: a systematic review and meta-analysis.

Metabolic acidosis is a common complication of kidney disease and can result in further disease progression. Alkali therapy has been used to treat metabolic acidosis for decades. However, some concerns have been raised regarding its safety and long-term tolerability. Existing data suggest that dietary interventions can be beneficial in the management of chronic kidney disease (CKD). This systematic review and meta-analysis aims to summarize findings from studies comparing dietary interventions with placebo/usual care/no treatment in the management of metabolic acidosis in outpatient adults with CKD. Medline, Embase, Cochrane Central, CINAHL, and Web of Science Core Collection were searched from inception to June 2022. Our primary outcome measure was change in serum bicarbonate. Any dietary intervention looking to manipulate dietary acid load was considered as an intervention. Data screening and extraction were performed by two independent reviewers. Random effects meta-analysis was performed to pool data. Dietary interventions resulted in clinically significant improvement in serum bicarbonate (mean difference (MD):2.98, 95% CI: [0.77, 5.19]; I2: 91%) and higher eGFR levels (MD: 3.16, 95%CI: [0.24, 6.08], I2: 67%) compared to controls. Serum potassium, albumin and body mass index remained unchanged. Dietary interventions were reported to be safe. Subgroup analyses indicated a superiority of plant-based over non-plant-based interventions in the improvement of acid-base balance and eGFR, however, these findings are from low quality and heterogenous studies. Our findings support the beneficial effects of dietary interventions aimed at reducing acid or adding base in the management of metabolic acidosis and kidney function in adults with CKD, with no adverse effects on serum potassium and nutritional status. Well-designed clinical trials looking at the treatment of metabolic acidosis with dietary interventions with a focus on adding base through fruit and vegetables are required.

Impact of Preoperative Continence on HoLEP Symptom Recovery: A Close Investigation of Patient-Reported Outcomes.

Introduction Holmium Laser Enucleation of the Prostate (HoLEP) is an increasingly utilized surgical intervention for Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS). It is unclear how pre-HoLEP voiding performance (including pre-HoLEP incontinence) affects post-HoLEP urinary symptom performance and recovery, which challenges effective patient counseling. Methods This is a single-institution retrospective analysis of 266 patients who underwent HoLEP. Pre-HoLEP continence status was determined by patient report. The Michigan Incontinence Symptom Index (MISI) was used to assess continence (severity and bother, severity broken into urge and stress). The International Prostate Symptom Score (IPSS) was used to assess LUTS (total IPSS score and Quality of Life (QoL)). Surveys were completed pre-operatively and one week (1wk), one month (1m), three months (3m), and one-year (1y) post-HoLEP. Primary outcome measures were MISI differences between groups at each time point. Results Of the 266 patients evaluated, 178 participants were continent and 88 were incontinent pre-HoLEP. Average age at time of HoLEP was 70.3 and 70.8 respectively, average preoperative prostate size measured by ultrasound or axial imaging was 109.0 g and 113.7 g, respectively. Based on MISI stress (#1-3) and urge (#4-6) items, pre-HoLEP Stress:Urge ratio in continent pre-HoLEP patients was 1.29:3.02. In the incontinent pre-HoLEP group, Stress:Urge was 2.45:6.18. MISI scores were statistically similar between cohorts at 1wk. Preop incontinent patients had a statistically and clinically significant improvement in MISI severity score at 1y post-HoLEP (5.62 n=11 vs 10.170 n=50, p=0.013). IPSS Total scores were statistically similar between cohorts at 1m and IPSS QoL scores were statistically similar at pre-op. At preop evaluation, urge symptoms were worse than stress symptoms in all cohorts. Conclusions Preoperative incontinence should not be considered a predictor of poor intermediate or long-term post-HoLEP outcomes. Pre-HoLEP incontinence is likely largely urge-related.

The DPP-4 inhibitor sitagliptin improves glycaemic control and early-stage diabetic nephropathy in adolescents with type 1 diabetes using the MiniMed 780G advanced hybrid closed-loop system: a randomised controlled trial.

Dipeptidyl peptidase-4 (DPP-4) inhibition has beneficial effects on various metabolic indicators in diabetes. Stromal cell-derived factor-1 (SDF-1) is expressed in diverse organs including the kidneys and is cleaved and inactivated by DPP-4 enzyme. The aim of this study was to conduct a randomised controlled trial to assess the effect of sitagliptin on diabetic nephropathy when used as an add-on therapy to the advanced hybrid closed-loop (AHCL) system in adolescents with type 1 diabetes and nephropathy. This open-label, parallel-group, randomised controlled trial took place at the Pediatric Diabetes Clinic, Ain Shams University, Egypt. Forty-six adolescents aged 14.13 ± 2.43 years on the MiniMed 780G system for at least 6 months before study, with HbA1c ≤69 mmol/mol (8.5%) and diabetic nephropathy in the form of microalbuminuria, were randomly assigned to two groups (n=23 for each) based on a computer-generated randomisation sequence. The intervention group received oral sitagliptin 50 mg for 3 months. The other group used AHCL only and served as a control group. The primary outcome measure was the change in urinary albumin/creatinine ratio (UACR) after 3 months of administration of sitagliptin. The key secondary outcome measure was the change from baseline in SDF-1 levels after treatment. Data for all participants were analysed. No significant difference was found between the groups as regards baseline clinical and laboratory characteristics as well as AHCL system settings (p>0.05). Serum SDF-1 levels were higher in all individuals with type 1 diabetes vs healthy control individuals (p<0.001). After 3 months, sitagliptin resulted in a significant decrease of SDF-1 levels from 3.58 ± 0.73 to 1.99 ± 0.76 ng/ml (p<0.001), together with improvement of UACR from 7.27 ± 2.41 to 1.32 ± 0.31 mg/mmol (p<0.001). In addition, sitagliptin reduced postprandial glucose, sensor glucose, coefficient of variation and total daily dose of insulin, while time in range 3.9-10.0 mmol/l (70-180 mg/dl) and insulin-to-carbohydrate ratio were significantly increased. Sitagliptin was safe and well-tolerated without severe hypoglycaemia or diabetic ketoacidosis. Sitagliptin as an add-on therapy to AHCL had a reno-protective effect for individuals with type 1 diabetes and diabetic nephropathy, in addition to the improvement of time in range while reducing glycaemic variability and without compromising safety. This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. ClinicalTrials.gov NCT06115460.

Preoperative Multidisciplinary Team Huddle Improves Communication and Safety for Unscheduled Cesarean Deliveries: A System Redesign Using Improvement Science.

Optimal communication between care teams is a critical component in providing safe, timely, and appropriate patient care. Labor and delivery (L&D) units experience rapidly changing clinical scenarios often requiring escalation in care and unplanned cesarean deliveries (CDs). The University of Cincinnati Medical Center (UCMC) is a 550-bed academic level 4 maternal care center with a 13-bed L&D unit in Cincinnati, OH. There are approximately 2500 deliveries/y with a CD rate of 33%. The L&D unit is staffed with dedicated anesthesia personnel 24 hours a day. In our L&D unit, there was widespread dissatisfaction with multidisciplinary communication surrounding unscheduled CD. Near-miss safety events in our obstetric unit were attributed to preoperative communication failures. Initial surveys identified challenges in preoperative communication among nursing, anesthesiology, and obstetric teams leading to potential risk for compromised care. Using the UC Health Performance Improvement Way, we first sought to understand the process leading up to unscheduled CD. Change ideas were developed based on observed failures in communication. Interventions were tested and refined through iterative plan-do-study-act (PDSA) cycles. One key intervention was the introduction of a bedside, multidisciplinary, patient-centered, pre-CD huddle attended by nursing, anesthesia, and obstetrics representatives using a standard checklist for critical information. Qualitative patient feedback was elicited to inform change efforts. We compared patient and procedure characteristics from the baseline and huddle implementation phases. Our primary outcome measure was the satisfaction of care team members with communication around unscheduled CD. A secondary outcome was the general anesthesia (GA) rate for unscheduled CD. Our key process measure was adherence to the preoperative huddle. We tracked decision-to-incision interval (DTI) as a balancing measure. Huddle adherence reached 96% for unscheduled CD within 6 months of testing and implementation. A combined survey of anesthesia, nursing, and obstetrics showed that satisfaction scores related to unscheduled CD communication improved from 3.3/5 to 4.7/5 after huddle implementation. The rate of GA use and the median DTI remained unchanged. Patients felt more engaged and reported positive experiences by being a part of the huddle discussion. In an academic obstetric unit, communication failures surrounding unscheduled CD were identified as a contributor to staff dissatisfaction and perception of safety risk. Implementation of a bedside multidisciplinary pre-CD huddle improved communication between teams and contributed to creating a culture of safety without causing significant delays in care.

Acceptance and commitment therapy for people with depressive and anxiety symptoms following acquired brain injury: Results of the BrainACT randomized controlled trial

ObjectiveThis study aimed to investigate the effectiveness of an adapted ACT intervention (BrainACT) in people who experience anxiety and/or depressive symptoms following acquired brain injury. MethodsThe study is a multicentre randomized controlled two-arm parallel trial. In total, 72 people who survived a stroke or traumatic brain injury were randomized into an eight-session ACT or control (i.e. psycho-education and relaxation) intervention. The primary outcome measures were the Hospital Anxiety and Depression Scale (HADS) and the Depression Anxiety and Stress Scale (DASS). Secondary outcomes were ACT process measures, participation, and quality of life. Outcome assessments were performed by trained assessors, blinded to treatment condition, pre-treatment, during treatment, post-treatment, and at 7 and 12 months follow-up. ResultsThere were no differences between groups on any outcome measure. Participants in both groups significantly improved on all outcome measures, except for participation frequency. More clinically relevant long-term improvements (i.e. recovered or reliable changes on the HADS) were found in favour of ACT for depressive and anxiety symptoms. ConclusionThe study was negative on the primary outcome measures. On an individual level, this study showed that especially on the long term ACT seems to show a more clinically relevant decrease in anxiety and depressive symptoms compared to an active control intervention. However, ACT was not superior in improving ACT-related processes such as psychological flexibility, cognitive defusion, and valued living nor in increasing participation or quality of life. Further large-scale group studies are warranted. Trial registrationThe study was originally registered in the Dutch Trial Register (now Clinical Trial Registry Platform), NL-OMON50203. Registered on 18/07/2018 and now to be found under https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON50203.