Primary Outcome Measure Research Articles

Effectiveness of community-based Baduanjin exercise intervention for older adults with varying frailty status: a randomized controlled trial

BackgroundDue to poorer exercise tolerance, it may be challenging for frail older adults to engage in moderate- or vigorous-intensity exercise. While low-intensity exercise interventions may be more feasible, its effectiveness for such population group remains unclear. We examined the effectiveness and implementation of community-based Baduanjin Qigong, a low-intensity exercise program in older adults with varying frailty status.MethodsA two-arm, multicenter assessor-blind parallel group randomized controlled trial was conducted at three local senior activity centers. Fifty-six community-dwelling older adults with low handgrip strength were randomly allocated to either the intervention (IG) or wait-list control (CG) group. The IG underwent a supervised 16-week Baduanjin exercise program at a frequency of 2–3 × 60 min sessions/week. The CG was instructed to maintain their usual activity and received a monthly health education talk. The primary outcome measures were knee extension strength, vital exhaustion, and fear of falling. Secondary outcome measures include physiological falls risk, handgrip strength, gait speed, timed up and go test, 30-second sit-to-stand, quality of life, depression, and frailty. All outcome measures were assessed at baseline and 4-month follow-up.ResultsOverall, there were no statistically significant differences in all outcome measures between CG and IG at 4-month follow-up. However, in exploratory compliance analysis, a statistically significant group x time interaction was found for vital exhaustion (B = -3.65, 95% CI [-7.13, -0.16], p = .047) among participants with at least 75% attendance. In post-hoc within-group comparisons, IG showed improved vital exhaustion by 4.31 points (95% CI [1.41, 7.20], d = 0.60). The average participant attendance rate was 81.3%. No major adverse events occurred, and all participants reported positive experiences with the exercise intervention.ConclusionsOur study demonstrated that Baduanjin is a safe, feasible, and acceptable exercise program that can be successfully implemented in community settings for older adults with varying frailty status. With good adherence, Baduanjin exercise could potentially be effective in alleviating vital exhaustion. However, the effectiveness of Baduanjin on physical performance, psychological measures and frailty in community-dwelling older adults remains equivocal.Trial registrationClinicalTrials.gov NCT04549103. Registered September 16, 2020.

Postoperative analgesic effectiveness of ultrasound-guided bilateral erector spinae plane block vs. rectus sheath block for midline abdominal surgery in a low- and middle-income country: a randomised controlled trial.

The use of erector spinae plane block and rectus sheath block for postoperative analgesia in midline abdominal procedures is becoming more common. However, the most effective and appropriate method remains unclear. We aimed to compare the postoperative analgesic effecacy of ultrasound-guided bilateral erector spinae plane blocks with rectus sheath blocks for midline abdominal surgery in a low- and middle-income country. We allocated randomly 72 patients aged 18-65 y undergoing midline abdominal surgery to an erector spinae plane block (n = 36) or a rectus sheath block (n = 36) utilising a prospective, parallel study design. Patients, care providers and outcome assessors were blinded to the interventions. The primary outcome measures were total postoperative analgesia consumption, postoperative pain severity and time to first rescue analgesic administration. Secondary outcomes included the incidence of postoperative complications and adverse events. Of 78 patients assessed for eligibility, six were excluded, leaving 72 for analysis. Patients allocated to erector spinae plane block had a lower mean (SD) postoperative opioid consumption compared with those allocated to rectus sheath block (3.5 (8.7) morphine milligram equivalents vs. 8.2 (2.8) morphine milligram equivalents, respectively; p = 0.003). Time to first analgesic request was greater in patients allocated to erector spinae plane block compared with those allocated to rectus sheath block (mean (95%CI) 16 (13-17) h vs. 12 (11-13) h, respectively; p < 0.001). There were no block-related complications in either group. Erector spinae plane blocks are more effective than rectus sheath blocks for the management of postoperative pain following midline abdominal surgery. Integration of erector spinae plane blocks into multimodal opioid-sparing analgesic strategies after midline abdominal surgeries may promote enhanced patient recovery in low-and middle-income countries.

Sex-related differences in clinical characteristics and in-hospital outcomes of patients in acute type A aortic dissection

ObjectiveThe aim of this study was to investigate sex-related differences in the clinical characteristics and hospital outcomes of patients undergoing surgery for acute type A aortic dissection (AAAD).MethodsThis study was a retrospective study. Patients who underwent surgery for AAAD at the Department of Cardiac Surgery, Fujian Medical University Union Hospital, from January 2014 to March 2023 were consecutively included. Data was extracted from electronic medical records. The primary outcome measure was in-hospital mortality, and secondary outcome measures included new-onset postoperative arrhythmia (POA), acute kidney injury (AKI), hepatic dysfunction, neurological complications, gastrointestinal hemorrhage, ICU length of stay, and hospital length of stay. Patients were divided into two groups based on sex, and data analysis was performed using SPSS 25.0 software.ResultsA total of 1137 subjects were included, with 863 males (75.9%) and 274 females (24.1%). There were statistically significant differences in age and BMI between the two groups (P < 0.05). There was no statistically significant difference in the incidence of pain at the onset between the two groups, but chest tightness in females was higher than in males (22.6% vs. 13.8%). Regarding primary outcomes, the in-hospital mortality rate was 11.1% for males and 10.6% for females (P = 0.803). There were no statistically significant differences between the groups in ICU days, length of hospitalization, neurological complications, or liver dysfunction (P > 0.05). The rate of POA in females was 4.7%, higher than in males (2.2%), but AKI and gastrointestinal hemorrhage were both higher in males than in females (P < 0.05). Multivariate analysis showed that age, white blood cell (WBC) counts, lactic acid, operation duration and prolonged mechanical ventilation (PMV) increased the risk of in-hospital mortality in male patients. Hypertension, WBC counts, lactic acid, and PMV increased the risk of in-hospital mortality in female patients.ConclusionDespite significant baseline characteristic differences between male and female AAAD patients, there were no significant differences in onset symptoms. The in-hospital mortality rates were similar between male and female patients, but the risk factors for in-hospital mortality differed.

Health-related quality of life in children and adolescents born very preterm and its correlates: a cross-sectional study

ObjectiveWe aimed to assess health-related quality of life (HRQOL) in a cohort of very preterm born children and adolescents (aged 5–16), and to compare it with their fullterm born siblings...

Transthyretin amyloidosis in patients with spinal stenosis who underwent spinal surgery: a systematic review and meta-analysis.

Accumulation of transthyretin amyloids (ATTR) is detected in ligamentum flavum in about 1/3 of patients underwent surgery for spinal stenosis. However, the significance of this finding is not known. The aim of this systematic review and meta-analysis is to analyze the incidence and importance of ATTR in patients with spinal stenosis who underwent spinal surgery. The primary outcome measure was incidence of ATTR in patients with spinal stenosis. English language observational studies published within 10 years period were searched in Pubmed and Taylor and Francis databases. Nine articles were included in the systematic review. The incidence of positive ATTR among patients who underwent lumbar spinal surgery was 48% (95%CI 38-58%). ATTR deposits were found in the lumbar region the most frequently. Seven studies showed that patients with positive ATTR were older than those with negative. Five studies investigated and found a significant relationship between the ligamentum flavum thickness and positive ATTR. Five studies investigated cardiac involvement among patients with positive ATTR. ATTR deposits are frequently found in older patients with spinal stenosis, especially in the lumbar region. The presence of ATTR deposits is related to ligamentum flavum thickness.

Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability

One in four older adults report difficulty walking, greatly increasing the risk of future disability and death. Though exercise improves mobility, too few older adults do it. While studies show that brief exercise sessions provide most of the benefit of longer sessions and that older adults note that “time” is a critical barrier to being active, what remains unknown is whether briefer RT sessions can improve mobility as well as, or better than, longer traditional sessions, possibly due to greater adherence. We present the design of a 12-month randomized controlled trial of 700 older adults with self-reported walking difficulty. Participants will be randomly assigned, in a 2 × 2 factorial design, to one of two home-based exercise programs: 1) Standard of Care: 45-min, three-times weekly sessions or 2) Experimental: 5-min daily sessions and to one of two doses of behavior change techniques (Standard or Enhanced) as part of their exercise program. The primary outcome measure is self-reported physical function. Secondary outcome measures include objectively measured lower extremity physical performance, walking endurance, balance, walking speed, strength and physical activity as well as self-reported falls, pain, fatigue and balance. This is one of the first studies to examine the clinical outcomes of brief exercise sessions, which may lead to a new generation of exercise programs that are optimized not only for impact, but for adherence as well.

Interdisciplinary multimodal pain therapy: does the dose make adifference? : Acomparison from routine clinical care

Interdisciplinary multimodal pain therapy (IMPT) is an established treatment for patients with severe chronic pain. Little evidence is available on the role of treatment dosage and, in particular, on the association between the duration of IMPT and treatment outcome. The aim of this retrospective study was to compare the medium-term treatment success of ashort inpatient (SIT, 1week) and along outpatient (LOT, 4weeks) IMPT with acomparable treatment concept and comparable therapy intensity (20 h/week) in patients with severe chronic pain. Patients in both groups completed the German Pain Questionnaire at the beginning and end of IMPT as well as after 3months. Primary outcome measures included pain-related impairment and average pain intensity at follow-up in patients of comparable sex, age as well as pain intensity and impairment at the beginning of the therapy. While both groups initially showed significant treatment effects in pain-related impairment and average pain intensity, LOT patients (n = 32) reported significantly better values in both variables at 3‑month follow-up compared with SIT patients (n = 32). This was due to sustained positive effects in LOT patients and worsening in the SIT group. The results indicate that initial treatment effects can be observed in both treatment settings, but alonger duration of therapy seems to favour the long-term stability of treatment effects.

Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial.

Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to reduce the decline of the optic nerve. Due to the extended and continuous treatments required for patients, complementary therapies are often considered alongside conventional treatments to enhance the effectiveness of the treatment. Acupuncture has demonstrated the potential to lower intraocular pressure in previous clinical trials, making it a promising glaucoma intervention. The primary objective of this study is to conduct a single-center randomized control trial involving patients with glaucoma. Acupuncture will be evaluated as an adjunctive therapy. The trial aims to explore its effectiveness for glaucoma. In this single-center randomized controlled trial, participants (N=50) with primary open-angle glaucoma will be randomly assigned to the treatment group, receiving ophthalmic acupuncture with "De Qi" sensation, or the control group, receiving minimum acupuncture stimulation on nonophthalmic acupoints. The intervention will consist of weekly acupuncture treatments for a total of 6 sessions. Participants will be assessed at 8 time points, which are baseline, during the intervention (6 times), and at a 3-month follow-up. The primary outcome measure is a change in the intraocular pressure before and after each acupuncture treatment. Secondary outcomes will include measurements of heart rate and blood pressure before and after acupuncture, best-corrected visual acuity, visual field, optical coherence tomography, optical coherence tomography angiography, the Glaucoma Symptom Scale, and the Glaucoma Quality of Life-15 questionnaire. Recruitment of participants for the trial commenced on June 28, 2023. A total of 10 participants have been enrolled to test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by December 2025. This trial uses rigorous methodology and comprehensive outcome measurements to assess the clinical efficacy of acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines. ClinicalTrials.gov NCT05753137; https://clinicaltrials.gov/study/NCT05753137. DERR1-10.2196/57888.

Effect of mediolateral leg perturbations on walking balance in people with chronic stroke: A randomized controlled trial.

Many people with chronic stroke (PwCS) exhibit deficits in step width modulation, an important strategy for walking balance. A single exposure to swing leg perturbations can temporarily strengthen this modulation. The objective of this parallel, double-blinded, randomized controlled trial was to investigate whether repeated perturbations cause sustained increases in step modulation (NCT02964039; funded by the VA). 54 PwCS at the Medical University of South Carolina were randomly assigned to one of three intervention groups: Control (n = 18), with minimal forces; Assistive (n = 18), pushing the swing leg toward a mechanically appropriate location; Perturbing (n = 18), pushing the swing leg away from a mechanically appropriate location. All intervention groups included 24 training sessions over 12-weeks with up to 30-minutes of treadmill walking while interfaced with a novel force-field and a 12-week follow-up period, with five interspersed assessment sessions. Our primary outcome measure was paretic step width modulation, the partial correlation between step width and pelvis displacement (ρSW). Secondarily, we quantified swing and stance leg contributions to step modulation, clinical assessments of walking balance and confidence, and real-world falls. Outcomes were analyzed for participants who completed all assessment sessions (n = 44). Only the Perturbing group exhibited significant increases in paretic ρSW, which were present after 4-weeks of training and sustained through follow-up (t = 2.42-3.17). These changes were due to improved control of paretic swing leg positioning. However, perturbation-induced changes in step modulation were not always significantly greater than those in the Control group, and clinical assessments were similar across intervention groups. Participants in the Perturbing group experienced a lower fall rate than those in the Control group (incidence rate ratio = 0.53), although our small sample size warrants caution. The present results indicate that perturbations can cause sustained modifications of targeted biomechanical characteristics of post-stroke gait, although such changes alone may be insufficient to change more complex clinical assessments.

Correlation between body mass index and gender-specific 28-day mortality in patients with sepsis: a retrospective cohort study.

To investigate the potential correlation between body mass index (BMI) and the 28-day mortality rate among sepsis patients and the gender difference in this association. The current research was a retrospective cohort study. A total of 14,883 male and female cohorts of sepsis patients were included in the Medical Information Mart for Intensive Care IV (MIMIC-IV V2.2) database. Patients in each gender cohort were further classified as underweight, normal weight, overweight, or obese according to BMI and the World Health Organization (WHO) BMI categories. The 28-day mortality from the date of ICU hospitalization was the primary outcome measure. The BMI and 28-day mortality exhibited an L-shaped relationship (p for nonlinearity <0.001) with significant gender-specific differences. Subgroup analysis revealed different association patterns between the male and female cohorts. Specifically, BMI and mortality exhibited a U-shaped curve relationship among the males (p for nonlinearity <0.001) and an L-shaped relationship among the females (p for nonlinearity = 0.045). This study proposes a link between extreme BMI and 28-day mortality in patients with sepsis. Underweight patients have an increased risk of mortality; however, this risk decreases in overweight and obese patients. Upon stratifying by sex, a U-shaped pattern was observed, indicating an association between BMI and 28-day mortality in males, while an L-shaped pattern emerged in females.

What determines the overall quality of postoperative pain management? Aquestion of perspective

The outcome domains pain intensity, pain-related interference, side effects, (treatment) information, participation and personal interaction have all been identified as relevant factors in the management of perioperative pain. However, it is not yet clear which of these are particularly significant for the subjectively perceived overall quality of postoperative pain management. Anewly developed questionnaire was used in this cross-sectional study to assess the relevance of these domains for patients and compare the relevance to healthcare professionals (HCP). The patient survey (n = 40) was conducted on the first postoperative day at Jena University Hospital, Germany. In order to investigate group differences, 63 HCP (disciplines: n = 15 anaesthesiology, n = 17 surgery, n = 31 nursing) were recruited. The questionnaire primarily included all pairwise comparisons between the domains with regard to the overall quality of postoperative pain management. The resulting sum scores for each domain were the primary outcome measure, which were analysed using generalized estimating equations. Within the group of patients, there were significant differences in the prioritization of the six outcome domains, with personal interaction followed by intensity and interference having received the highest ratings. There were also significant differences within the domains between the perspectives of patients and HCP, as well as between the HCP themselves. The study demonstrates that personal interaction and the reduction of pain intensity and interference are three key factors that are significant for patients' experience of postoperative pain management. However, the extent to which the harmonisation of these three factors with those given prominence by HCP would positively impact postoperative pain management remains unclear and should be investigated further.

A Modified Nonendoscopic Subperiosteal Brow Lift Via Transblepharoplasty Incision

Purpose: To evaluate a minimally invasive transblepharoplasty subperiosteal suture-suspended brow lift that was developed by the senior investigator (N.A.N.) to restore the brow complex in the setting of visually significant brow ptosis. Methods: A retrospective review was performed of all patients who underwent this procedure by a single surgeon (N.A.N.) from 2008 to 2022. The primary outcome measure was the change in margin-reflex distance 1 (MRD1) and brow-reflex distance (BRD), measured from the pupillary reflex to the first row of brow cilia. Results: A total of 32 patients (61 eyes) were included, with an average age of 68% and 53% were female. Brow ptosis in 3 patients was unilateral due to unresolved Bell’s Palsy. The average follow-up was 76 days. Statistical analysis of bilateral cases revealed post-operative brow elevation (mean right BRD +2.82 mm [ P &lt; .001] and left BRD +2.42 mm [ P &lt; .001]) and upper eyelid elevation (mean right MRD1 +1.99 mm [ P &lt; .001] and left MRD1 +1.71 [ P &lt; .001]). Brow ptosis recurred in 3 patients bilaterally, and there were no long-term complications. Conclusions: This surgical technique is an effective and safe minimally invasive option for patients with brow ptosis. It completed under light sedation without the need for endoscopic equipment.

The Effect of Video-Based Action Observation Training and Live Action Observation Training on Motor Function, Activity Participation, and Secondary Outcome Measures in Children With Spastic Diparetic Cerebral Palsy: A Randomized Controlled Study.

This study aimed to investigate the effects of Video-Based Action Observation Training and Live Action Observation Training on motor function, activity participation, and secondary outcome measures in children with spastic diparetic cerebral palsy (CP). Thirty-nine children with spastic diparetic cerebral palsy, aged 5-14 years, with Gross Motor Function Classification System I-III, were distributed in equal numbers to any of the Video-Based Action Observation Training (conventional physiotherapy + Video-Based Action Observation Training), Live Action Observation Training (conventional physiotherapy + Live Action Observation Training), and control (conventional physiotherapy) groups through stratified randomization. For 8 weeks, action observation training groups received 20 minutes of conventional physiotherapy followed by 20 minutes of action observation training, and the control group received 40 minutes of conventional physiotherapy. Primary outcome measures were Gross Motor Function Measurement and Child and Adolescent Scale of Participation, secondary outcome measures were Pediatric Berg Balance Scale, timed-up-and-go test, five times sit-to-stand test (FTSST), Gillette Functional Assessment Questionnaire (GFAQ), and 1-minute walk test (1MWT). Improvements were observed in all other evaluation parameters of the groups except Gross Motor Function Measurement-lying and rolling (P = .066) in the Live Action Observation Training Group, and lying and rolling (P = .317) and crawling and kneeling (P = .063) motor subtests and Gillette Functional Assessment Questionnaire-walking scale (P = .513) in the control group. Comparisons of the increases in all other measurements between the groups, except for the dimensions of Gross Motor Function Measurement-lying and rolling (P = .172), were statistically significant (P < .05) and this difference was in favor of action observation training. It was found that 2 different AOTs applied in addition to conventional physiotherapy in children with spastic diparetic cerebral palsy were more effective on all outcomes than was conventional physiotherapy alone.

Comparison of remimazolam and midazolam for preventing intraoperative nausea and vomiting during cesarean section under spinal anesthesia: a randomized controlled trial.

Preventing intraoperative nausea and vomiting (IONV) is crucial for maternal safety during cesarean section under spinal anesthesia. While midazolam is known to prevent IONV, we hypothesized that remimazolam would be superior due to its minimal hemodynamic effects. We compared the effects of the two drugs on IONV. Parturients scheduled for cesarean section were randomly assigned to receive either midazolam or remimazolam. They received midazolam 2 mg or remimazolam 5 mg, with additional doses administered upon request. The primary outcome measure was the incidence of newly developed IONV during sedation. Other outcomes included overall IONV, rescue antiemetic use, shivering, hemodynamic variables, sedation scale scores, and satisfaction scores. Data from 80 participants were analyzed. Deeper sedation was induced in the remimazolam group (PGroup × Time < 0.001) despite comparable hemodynamic trends between the groups. The incidence of overall IONV was comparable between the two groups (27.5% in the midazolam group vs. 17.5% in the remimazolam group, absolute risk reduction [ARR]: 0.100, 95% confidence interval [CI] [-0.082, 0.282], P = 0.284); however, newly developed IONV during sedation was significantly reduced in the remimazolam group (20.0% vs. 5.0%, ARR: 0.150, 95% CI [0.009, 0.291], P = 0.043). The need for rescue antiemetics was also lower in the remimazolam group (15.0% vs. 2.5%, ARR: 0.125, 95% CI [0.004, 0.246], P = 0.048). Remimazolam significantly reduced the incidence and severity of newly developed IONV compared with midazolam, with minimal impact on hemodynamics, making it a useful sedative option for cesarean section.

Percutaneous Deep Venous Arterialization by Balloon Angioplasty without Stent Implantation for Patients with Chronic Limb-Threatening Ischemia Undergoing Hemodialysis: A Retrospective Cohort, Single-Center, Single-Arm Study.

This retrospective, single-center study aimed to determine the efficacy of percutaneous deep venous arterialization in patients on hemodialysis with chronic limb-threatening ischemia. Twenty-one consecutive limbs on hemodialysis with chronic limb-threatening ischemia were treated with percutaneous deep venous arterialization using balloon angioplasty following a failed pedal arterial reconstruction between May 2021 and June 2022. An arteriovenous fistula near the ankle joint was created to ensure sufficient venous flow reversal to the pedal veins. In case of occlusion of the tibial artery, a guidewire was advanced (subintimal) to the ankle joint vicinity was technically important. The primary outcome measures were the 6-month complete wound healing and freedom from major amputation rates; the secondary outcome measure was the 6-month amputation-free survival. Occlusion of all pedal arteries was observed in 17 limbs (81.0%). Arteriovenous fistulas were predominantly created at the distal portions of the posterior tibial artery and vein in 18 limbs (85.7%). No extravasation at the fistulas was observed. Re-intervention was required in 16 limbs (76.2%) due to tibial artery or deep vein occlusion. The 6-month complete wound healing rate was 42.9% (nine limbs), with a median healing time of 85 days (interquartile range: 58-151 days). The 6-month freedom from major amputation and amputation-free survival rates were 90.5% (19 limbs) and 61.9% (13 limbs), respectively. Balloon angioplasty without stent implantation for percutaneous deep venous arterialization is promising for improving the complete wound healing and amputation-free survival rates after pedal artery reconstruction failure. Level 3b, retrospective cohort study.

Directly Isolated Allogeneic Virus–Specific T Cells in Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) is a life-threatening viral infection with no approved antiviral treatment. To determine whether restoring the compromised immune system of patients with PML with directly isolated allogeneic virus-specific (DIAVIS) T cells is a promising therapeutic strategy, especially if other curative options are absent. A retrospective case series of patients with PML who were treated with DIAVIS T cells was conducted between March 2020 and February 2022. T cells were isolated from healthy donors within 24 hours and targeted against the BK polyomavirus. Patients with PML were treated monocentrically. Eligibility for treatment with DIAVIS T cells was assessed for patients with confirmed PML, and exclusion criteria included stable PML disease and previous treatment with natalizumab. Fresh DIAVIS T cells were administered with a maximum dose of 2 × 104 CD3+ cells/kg body weight. Remaining T cells were cryopreserved in divided doses and administered in additional treatments approximately 2 and 6 weeks later. Primary outcome measures were clinical response and survival of patients, compared with the outcomes of a historical reference group of PML cases receiving best supportive treatment (BST) and with recently published real-world data of patients with PML who were treated with immune checkpoint inhibition. The study cohort consisted of 28 patients (median [IQR] age, 60 [51-72] years; 20 male [71.4%]). Twenty-two patients (79%) treated with DIAVIS T cells showed response, resulting in significant clinical stabilization or improvement and a reduction in viral load. Six individuals (21%) were classified as nonresponders, deteriorated rapidly, and died, as did 2 other patients during a 12-month follow-up. Older age was the only predictor of a poor treatment response. Survival analysis revealed better 12-month survival rates (hazard ratio, 0.42; 95% CI, 0.24-0.73; P =.02) from diagnosis for patients treated with DIAVIS T cells (18 of 26 [69%]; 12-mo survival rate, 69%) compared with historical controls with BST (57 of 113 [50%]; 12-mo survival rate, including censored data, 45%). This case series of DIAVIS T-cell therapy in PML provides first class IV evidence suggesting efficacy to reduce mortality and improve functional outcome. Further prospective studies are required to confirm these results.

Culturally appropriate options for diabetes self‐management: Results from a patient‐centered comparative effectiveness study

AbstractThis project compared the effectiveness of two evidence‐based models of culturally competent diabetes health promotion: the diabetes self‐management support empowerment model (DSMS) and the chronic care model (CCM). Our primary outcome was improvement in patient capacity for diabetes self‐management as measured by the diabetes knowledge questionnaire (DKQ) and the patient activation measure (PAM). Our secondary outcome was patient success at diabetes self‐management as measured by improvement in A1c, depression scores using the PHQ‐9, and body mass index (BMI). We also gathered data on the cultural competence of the program using the Consumer Assessment of Healthcare Providers and Systems Cultural Competence Set. We compared patient outcomes in two existing sites in Albuquerque, New Mexico that serve a large population of Latinx diabetes patients from low‐income households. Participants were enrolled as dyads—a patient participant (n = 226) and a social support participant (n = 226). Outcomes over time and by program were analyzed using longitudinal linear mixed modeling, adjusted for patient participant demographic characteristics and other potential confounding covariates. Secondary outcomes were also adjusted for potential confounders. Interactions with both time and program helped to assess outcomes. This study did not find a difference between the two sites with respect to the primary outcome measures and only one of the three secondary outcomes showed differential results. The main difference between programs was that depression decreased more for CCM than for DSMS. An exploratory, subgroup analysis revealed that at CCM, patient participants with a very high A1c (&gt;10) demonstrated a clinically meaningful decrease. However, given the higher cultural competence rating for the CCM, statistically significant improvement in depression, and the importance of social support to the patients, results suggest that a culturally and contextually situated diabetes self‐management and education program design may deliver benefit for patients, especially for patients with higher A1c levels.Key Points The team was interdisciplinary. The information presented describes results of both qualitative and quantitative data and involves interpretations that are interdisciplinary in nature. The study design used methods from multiple disciplines.

Association of computed tomography-derived body composition and complications after colorectal cancer surgery: A systematic review and meta-analysis.

The prediction of the risk of developing complications after colorectal surgery for colorectal carcinoma remains imprecise. Body composition measurements on a computed tomography (CT) scan can potentially contribute to a better preoperative risk assessment. The aim of this systematic review is to evaluate the evidence for the use of body composition measurements on CT scans to predict short-term complications after colorectal cancer surgery. A literature search (in PubMed, Embase and Web of Science) was performed up to 1 August 2022. Two researchers independently screened the articles, extracted data and assessed the quality of the studies using the Quality in Prognosis Studies tool. The primary outcome measure was the occurrence of complications within 30days after surgery. Meta-analysis was conducted using a random-effects model to synthesize a pooled odds ratio (OR). The study protocol was registered in PROSPERO (CRD42021281010). Forty-five articles with a total of 16537 patients were included. In total, 26 body composition measures were investigated: 8 muscle-related measures, 11 adipose tissue measures, 4 combined muscle and adipose tissue measures, and 3 other measures. These were investigated as potential predictors for more than 50 differently defined postoperative complications. Meta-analysis was only possible for two measurements and showed that higher amounts of visceral fat increase the risk of developing overall complications (OR: 2.52 [1.58-4.00], P<0.0001) and anastomotic leakage (OR: 1.76 [1.17-2.65], P=0.006). A wide variety of body composition measurements on preoperative CT scans have been investigated as a predictive factor for postoperative complications. Visceral fat appeared to be associated with overall complications and anastomotic leakage; however, the association is weak, and its clinical relevance or applicability is questionable. The current evidence is limited by methodological heterogeneity and the risk of bias. To improve comparability of results across studies and improve decision-making, future studies should use standardized methods for measuring body composition on CT scans, outcome definitions and statistical analyses.

7991 A Quality Improvement Initiative to Increase Documentation of Carbohydrate Ratios and Correction Factors on Insulin Sliding Scales

Abstract Disclosure: R.J. Vitale: None. C. Lu: None. A. Sonawalla: None. T.K. Maxwell: None. S. Nanavati: None. N.E. Renthal: None. E.T. Rhodes: None. C.E. Cherella: None. Background: In the management of insulin-dependent diabetes mellitus, sliding scale (SS) tables - which contain precalculated insulin doses for ranges of blood glucose and carbohydrate intake, usually based on a carbohydrate ratio (CR) and correction factor (CF) - provide a safer alternative for families with limited health literacy and numeracy. However, as insulin needs change, adjusting SS tables can be more difficult than adjusting CRs and CFs, which can cause less frequent or non-standard adjustments in SS tables, result in potential errors, and lead to disparities in the quality of care for these patients. We identified challenges to standardized SS documentation and adjustment at our institution and conducted a quality improvement (QI) initiative to address this problem. We aimed to increase the use of CR/CF to generate and adjust SS to improve the ease and accuracy of SS adjustments and ultimately improve care for this vulnerable patient population. Methods: Our goal was to increase the proportion of patients with diabetes mellitus discharged with CR/CF documented on the most recent SS in the medical record (the primary outcome measure) by 20% over 12 months. The process measure was clinician-reported utilization of CR/CF when generating or adjusting SS. To achieve our goal, we made two process improvements and used Plan-Do-Study-Act cycles to evaluate them. First, we standardized the template for documentation of the SS which also prompted inclusion of the CR/CF to preserve it for future adjustments. Second, we developed a Microsoft Excel SS generator based on clinician input of CR/CF. Clinicians were educated about the importance of CR/CF documentation and were taught to use the new process. SS documentation of CR/CF in the medical record was evaluated through monthly chart review and tracked on a run chart. Clinicians were periodically surveyed on the frequency of use of CR/CF in the creation of SS. Results: The median value of SS that included CR/CF documentation in medical records increased from 0% at baseline to 58% after the interventions. Reported use of CR/CF to make and adjust SS increased from 6/15 (40%) to 6/7 (86%). Provider qualitative feedback on the new process was positive. Conclusion: In this QI project, the implementation of a template that promoted documentation of CR/CF, and a standardized and automated SS calculator that generated SS based on CR/CF, led to both increased documentation of CR/CF for SS, and increased clinician-reported use of CR/CF to adjust SS. The latter may indicate a decrease in barriers to adjusting SS regimens. By facilitating adjustment, this low-cost, reproducible system could increase frequency of changes to SS and may help to improve the quality of care for children with diabetes mellitus using SS. Presentation: 6/2/2024

Predictive factors of major low anterior resection syndrome after surgery for rectal tumors.

To describe the epidemiological and clinical data of impaired functional outcome secondary to anterior resection of the rectum and to identify the predictive factors of major low anterior resection syndrome (LARS) Methods: This retrospective study considered patients operated on for rectal tumors in surgical department in our hospital, between January 1st,2009 and December 31st, 2021. The primary outcome measure was the development of a major LARS immediately or after stoma closure. In order to identify independent predictors of major LARS, patients were divided into two groups: the "Major LARS" group and the "No Major LARS" group, and then we carried out a descriptive study, followed by an analytical study with logistic regression. We enrolled 42 patients operated for rectal tumor and had an anterior resection. Half of our patients developed LARS of which 14 developed major LARS. The median time to onset of LARS symptoms was 9 [2 -24] months. At the end of this study, 2 factors were retained: age (OR=2.48; CI95% [1.2- 5.10], p=0.012) and pT3T4 stage (OR=5.95; CI95% [1.07- 33.33], p=0.041) as independent predictive factors of a major LARS. Neoadjuvant therapy was also a risk factor for major LARS in our study with a statistically significant difference (p=0.025) between the two groups "Major LARS" and "No major LARS". LARS should be appropriately considered in the management of rectal cancer. Based on our results and data from the literature, age and mesorectal invasion were found to be independent predictors of major LARS.