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1.
Prevalence of chronic kidney disease in Tunisian diabetics: the TUN-CKDD survey.
Labidi, J, Harzallah, A, Kaab, BB, Mami, I, Agrebi, S, Azzabi, A, Chargui, S, Hadj-Brahim, M, Hammouda, M, Azaiez, S, et al
BMC nephrology. 2024;(1):67
Abstract
BACKGROUND In Tunisia, the prevalence of diabetes mellitus increased from 15.5% on 2016 to 23% by 2023. While Chronic Kidney Disease (CKD) stills the most dreaded complications of diabetes, studies on the prevalence of chronic kidney disease non-dialysis diet are scarce. The aim of this study was to assess the prevalence of chronic kidney disease among the Tunisian diabetic population based on investigators' specialty, demographic criteria (gender, age, duration of diabetes and geographic distribution) and diagnosis criteria (albuminuria and/or eGFR). METHODS This observational, multicentric, and cross-sectional study enrolled all diabetic subjects from all regions of Tunisia with at least 3 months of follow-up before the inclusion date, from 09 January to 08 February 2023. CKD diagnosis was established based on the KDIGO guidelines. The study was carried out at medical departments and ambulatory clinics of different healthcare providers. Baseline data were collected by investigators using an electronic case report form (eCRF). Continuous variables were described by means, median, standard deviation, and quartiles. Categorical data were tabulated in frequencies and percentages. RESULTS The overall prevalence of CKD among the 10,145 enrolled patients with diabetes mellitus was 38.7% with a 95%CI [37.8-39.6%]. 50.9% were male, with a mean age of 67.5 (± 11.3) years. The mean diabetes duration was 16.1 years (± 8.9). The highest CKD prevalence was noted among nephrologists (82.2%), while it was similar between the cardiologists and the primary care physicians (30.0%). CKD prevalence was highest among males (43.0% versus 35.1%) and increased proportionally with patients' age and diabetes duration. CKD was more frequent in the Mid-East Area when compared to other regions (49.9% versus 25.3 to 40.1% in other regions). Albuminuria was present within 6.6% of subjects with CKD, and it was found an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² within 13.3% of subjects wit h CKD. 18.9% had both criteria. CONCLUSIONS In Tunisia, CKD among diabetics had a prevalence of 38.7%, approaching European prevalence. The prevalence discrepancy worldwide of CKD can be improved with a larger population size and by implementing standardized practices.
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2.
Breath metabolomics for diagnosis of acute respiratory distress syndrome.
Zhang, S, Hagens, LA, Heijnen, NFL, Smit, MR, Brinkman, P, Fenn, D, van der Poll, T, Schultz, MJ, Bergmans, DCJJ, Schnabel, RM, et al
Critical care (London, England). 2024;(1):96
Abstract
BACKGROUND Acute respiratory distress syndrome (ARDS) poses challenges in early identification. Exhaled breath contains metabolites reflective of pulmonary inflammation. AIM: To evaluate the diagnostic accuracy of breath metabolites for ARDS in invasively ventilated intensive care unit (ICU) patients. METHODS This two-center observational study included critically ill patients receiving invasive ventilation. Gas chromatography and mass spectrometry (GC-MS) was used to quantify the exhaled metabolites. The Berlin definition of ARDS was assessed by three experts to categorize all patients into "certain ARDS", "certain no ARDS" and "uncertain ARDS" groups. The patients with "certain" labels from one hospital formed the derivation cohort used to train a classifier built based on the five most significant breath metabolites. The diagnostic accuracy of the classifier was assessed in all patients from the second hospital and combined with the lung injury prediction score (LIPS). RESULTS A total of 499 patients were included in this study. Three hundred fifty-seven patients were included in the derivation cohort (60 with certain ARDS; 17%), and 142 patients in the validation cohort (47 with certain ARDS; 33%). The metabolites 1-methylpyrrole, 1,3,5-trifluorobenzene, methoxyacetic acid, 2-methylfuran and 2-methyl-1-propanol were included in the classifier. The classifier had an area under the receiver operating characteristics curve (AUROCC) of 0.71 (CI 0.63-0.78) in the derivation cohort and 0.63 (CI 0.52-0.74) in the validation cohort. Combining the breath test with the LIPS does not significantly enhance the diagnostic performance. CONCLUSION An exhaled breath metabolomics-based classifier has moderate diagnostic accuracy for ARDS but was not sufficiently accurate for clinical use, even after combination with a clinical prediction score.
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3.
Integrated Text Messaging (ITM) for people attending cardiac and pulmonary rehabilitation: A multicentre randomised controlled trial.
Redfern, J, Singleton, AC, Raeside, R, Santo, K, Hafiz, N, Spencer, L, Leung, RW, Roberts, M, King, M, Cho, JG, et al
Annals of physical and rehabilitation medicine. 2024;(3):101800
Abstract
BACKGROUND People living with cardiac and respiratory disease require improved post-hospital support that is readily available and efficient. OBJECTIVES To 1) test the effectiveness of an automated, semi-personalised text message support program on clinical and lifestyle outcomes amongst people attending cardiac and pulmonary rehabilitation. Also, 2) to evaluate the program's acceptability and utility using patient-reported outcome and experience measures. METHODS Multicentre randomised controlled trial (3:1, intervention:control) amongst cardiac and pulmonary rehabilitation attendees. Control received usual care (no message program). Intervention also received a 6-month text message lifestyle and support program. Primary outcome was 6-minute walk distance (6MWD). Secondary outcomes included clinical measures, lifestyle, patient-reported outcome and experience measures, medication adherence and rehabilitation attendance. RESULTS A total of 316 participants were recruited. They had a mean age of 66.7 (SD 10.1) years. Sixty percent were male (190/316) and 156 were cardiac rehabilitation participants. The cohort's mean baseline 6MWD was higher in the intervention than the control group. At 6 months, 6MWD improved in both groups; it was significantly greater amongst intervention than control participants (unadjusted mean difference of 43.4 m, 95 % CI 4.3 to 82.4; P = 0.0296). After adjustment for baseline values, there was no significant difference between intervention and control groups for 6MWD (adjusted mean difference 2.2 m, -21.2 to 25.6; P = 0·85), medication adherence, or cardiovascular risk factors. At 6-month follow-up, intervention participants reported significantly lower depression scores (adjusted mean difference -1.3, 95 % CI -2.2 to -0.3; P = 0.0124) and CAT scores (adjusted mean difference -3.9, 95 % CI -6.6 to -1.3; P = 0.0038), and significantly lower anxiety (adjusted mean difference -1.1, 95 %CI -2.1 to 0; P = 0.0456). Most participants (86 %) read most of their messages and strongly/agreed that the intervention was easy to understand (99 %) and useful (86 %). CONCLUSIONS An educational and supportive text message program for cardiac and pulmonary rehabilitation attendees improved anxiety and depression plus program attendance. The program was acceptable to, and useful for, participants and would be suitable for implementation alongside rehabilitation programs. TRIAL REGISTRATION NUMBER ACTRN12616001167459.
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4.
Comments on Oral Sulfate Solution Is as Effective as Polyethylene Glycol with Ascorbic Acid in a Split Method for Bowel Preparation in Patients with Inactive Ulcerative Colitis: A Randomized, Multicenter, and Single-Blind Clinical Trial.
Kim, JE
Gut and liver. 2024;(1):192-193
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5.
A Multicenter, Randomized, Open-Label Study to Compare the Effects of Gemigliptin Add-on or Escalation of Metformin Dose on Glycemic Control and Safety in Patients with Inadequately Controlled Type 2 Diabetes Mellitus Treated with Metformin and SGLT-2 Inhibitors (SO GOOD Study).
Kim, HJ, Noh, JH, Moon, MK, Choi, SH, Ko, SH, Rhee, EJ, Hur, KY, Jeong, IK
Journal of diabetes research. 2024;:8915591
Abstract
BACKGROUND We aimed to compare efficacy and safety between gemigliptin add-on and escalation of the metformin dose in patients with inadequately controlled type 2 diabetes mellitus (T2DM) despite treatment with metformin and SGLT2 inhibitors. METHODS This study was a multicenter, randomized, open-label, active-controlled, parallel-group comparative study. Patients with T2DM uncontrolled on metformin and SGLT2 inhibitors were randomized to receive gemigliptin 50 mg as an add-on (GEM group, n = 37) or escalation of the metformin dose (500 mg, MET group, n = 38) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to week 24. RESULTS At weeks 12 and 24, the reduction in HbA1c levels was significantly greater in the GEM group than in the MET group (GEM vs. MET = -0.64% ± 0.34% vs. -0.36% ± 0.50%, p = 0.009 at week 12; -0.61% ± 0.35% vs. -0.33% ± 0.70%, p = 0.045 at week 24). The proportions of patients who achieved target HbA1c levels of <7.0% at weeks 12 and 24 and <6.5% at week 12 were greater in the GEM group than in the MET group. An index of β-cell function was also significantly improved in the GEM group. The safety profiles were similar between the two groups. CONCLUSIONS Gemigliptin add-on therapy may be more effective than metformin dose escalation in patients with T2DM insufficiently controlled using metformin and SGLT2 inhibitors, without safety concerns. This trial is registered with CRIS_number: KCT0003520.
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6.
Association of possible sarcopenia with all-cause mortality in patients with solid cancer: A nationwide multicenter cohort study.
Yin, L, Song, C, Cui, J, Lin, X, Li, N, Fan, Y, Zhang, L, Liu, J, Chong, F, Cong, M, et al
The journal of nutrition, health & aging. 2024;(1):100023
Abstract
OBJECTIVES The concept of possible sarcopenia (PS) was recently introduced to enable timely intervention in settings without the technologies required to make a full diagnosis of sarcopenia. This study aimed to investigate the association between PS and all-cause mortality in patients with solid cancer. DESIGN Retrospective observational study. SETTING AND PARTICIPANTS 13,736 patients with 16 types of solid cancer who were ≥18 years old. MEASUREMENTS The presence of both a low calf circumference (men <34 cm or women <33 cm) and low handgrip strength (men <28 kg or women <18 kg) was considered to indicate PS. Harrell's C-index was used to assess prognostic value and the association of PS with mortality was estimated by calculating multivariable-adjusted hazard ratios (HRs). RESULTS The study enrolled 7207 men and 6529 women (median age = 57.8 years). During a median follow-up of 43 months, 3150 deaths occurred. PS showed higher Harrell's C-index (0.549, 95%CI = [0.541, 0.557]) than the low calf circumference (0.541, 95%CI = [0.531, 0.551], P = 0.037) or low handgrip strength (0.542, 95%CI = [0.532, 0.552], P = 0.026). PS was associated with increased mortality risk in both univariate (HR = 1.587, 95%CI = [1.476, 1.708]) and multivariable-adjusted models (HR = 1.190, 95%CI = [1.094, 1.293]). Sensitivity analyses showed that the association of PS with mortality was robust in different covariate subgroups, which also held after excluding those patients who died within the first 3 months (HR = 1.162, 95%CI = [1.060, 1.273]), 6 months (HR = 1.150, 95%CI = [1.039, 1.274]) and 12 months (HR = 1.139, 95%CI = [1.002, 1.296]) after enrollment. CONCLUSION PS could independently and robustly predict all-cause mortality in patients with solid cancer. These findings imply the importance of including PS assessment in routine cancer care to provide significant prognostic information to help mitigate sarcopenia-related premature deaths.
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7.
Clinical Impact of Supplementation with Pasteurized Donor Human Milk by High-Temperature Short-Time Method versus Holder Method in Extremely Low Birth Weight Infants: A Multicentre Randomized Controlled Trial.
García-Lara, NR, Escuder-Vieco, D, Cabrera-Lafuente, M, Keller, K, De Diego-Poncela, C, Jiménez-González, C, Núñez-Ramos, R, Flores-Antón, B, Escribano-Palomino, E, Alonso-Díaz, C, et al
Nutrients. 2024;(7)
Abstract
Nosocomial infections are a frequent and serious problem in extremely low birth weight (ELBW) infants. Donor human milk (DHM) is the best alternative for feeding these babies when mother's own milk (MOM) is not available. Recently, a patented prototype of a High-Temperature Short-Time (HTST) pasteurizer adapted to a human milk bank setting showed a lesser impact on immunologic components. We designed a multicentre randomized controlled trial that investigates whether, in ELBW infants with an insufficient MOM supply, the administration of HTST pasteurized DHM reduces the incidence of confirmed catheter-associated sepsis compared to DHM pasteurized with the Holder method. From birth until 34 weeks postmenstrual age, patients included in the study received DHM, as a supplement, pasteurized by the Holder or HTST method. A total of 213 patients were randomized; 79 (HTST group) and 81 (Holder group) were included in the analysis. We found no difference in the frequency of nosocomial sepsis between the patients of the two methods-41.8% (33/79) of HTST group patients versus 45.7% (37/81) of Holder group patients, relative risk 0.91 (0.64-1.3), p = 0.62. In conclusion, when MOM is not available, supplementing during admission with DHM pasteurized by the HTST versus Holder method might not have an impact on the incidence of catheter-associated sepsis.
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8.
Preoperative supine time for adrenal venous sampling: a prospective randomized controlled trial.
He, M, Zhang, Y, Song, X, Zhang, T, Yu, H, Ji, Y, Gong, S, Chai, P, Chen, J, Wang, S, et al
Trials. 2024;(1):14
Abstract
BACKGROUND Primary aldosteronism (P.A.) is the most common form of secondary hypertension, accounting for 5% of hypertensive patients and 17-23% of patients with resistant hypertension. Compared to primary hypertension, P.A. is more prone to cause severe organ damage and even early death. Adrenal venous sampling (AVS) is a practical confirmatory test for subtyping aldosterone-producing adenoma and bilateral adrenal hyperplasia, helping physicians to make an accurate decision between surgery or medication. According to guidelines, supine in bed before AVS is recommended for a desirable result of AVS. However, investigations about the most optimal preoperative supine time before AVS are lacking. METHODS/DESIGN This is a multi-center prospective randomized controlled study. One hundred twenty patients diagnosed as P.A. and willing for AVS examination will be included. Participants will be randomly allocated to a 15-min supine time group or 2-h supine time group. The primary outcome is the degree of biochemical remission (serum potassium and orthostatic ARR). The secondary outcomes are degrees of clinical remission (blood pressure, type and dose of antihypertensive drugs), the technical success rate, and the adverse event of AVS (selective index ≥ 2 is considered successful surgery without corticotropin stimulation). DISCUSSION P.A. is an intractable public health problem, and many techniques including AVS have been developed to identify this disease correctly. This study will help to understand whether the length of preoperative supine time would affect the diagnostic efficacy of AVS and thus help to formulate a more reasonable AVS procedure. TRIAL REGISTRATION ClinicalTrials.gov NCT05658705. Registered on 10 September 2022.
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9.
Comprehensive evaluation of serum hepatic proteins in predicting prognosis among cancer patients with cachexia: an observational cohort study.
Huang, JX, Zhang, X, Tang, M, Zhang, Q, Deng, L, Song, CH, Li, W, Shi, HP, Cong, MH
BMC cancer. 2024;(1):293
Abstract
BACKGROUND Hepatic proteins, including albumin, prealbumin, and transferrin have been confirmed to be prognostic predictors in various cancers. This study aimed to comprehensively assess the prognostic value of these three serum markers in patients with cancer cachexia. METHODS This multicenter prospective cohort study included 1303 cancer cachexia patients, among whom 592 deaths occurred during a median follow-up of 20.23 months. The definition of cachexia was based on the 2011 international consensus. Concordance index (C-index) and receiver operating characteristic (ROC) curves were applied to compare the prognostic performance. The primary outcome was overall survival, which was calculated using the Kaplan-Meier method generated by log-rank test. A Cox proportional hazard regression model was used to identify independent predictors associated with survival. The secondary outcomes included 90-days mortality and quality of life (QoL). RESULTS C-index and ROC curves showed that albumin had the most accurate predictive capacity for survival, followed by transferrin and prealbumin. Multivariate Cox analysis confirmed that low albumin (hazard ratio [HR] = 1.51, 95% confidence interval [95%CI] = 1.28-1.80, P < 0.001), prealbumin (HR = 1.42, 95%CI = 1.19-1.69, P < 0.001), and transferrin (HR = 1.50, 95%CI = 1.25-1.80, P < 0.001) were independent risk factors for long-term survival in cancer patients with cachexia. In subgroup analysis, the prognostic value of low albumin was significant in patients with upper gastrointestinal, hepatobiliary and pancreatic, and colorectal cancers; low prealbumin was significant in colorectal cancer; and low transferrin was significant in patients with upper gastrointestinal and colorectal cancer. All three hepatic proteins were valuable as prognostic predictors for patients with advanced (Stage III and IV) cancer with cachexia. The risks of 90-days mortality and impaired QoL were higher in cachexia patients with low albumin, prealbumin, and transferrin levels. CONCLUSION Low albumin, prealbumin, and transferrin levels were all independent prognostic factors affecting patients with cancer cachexia, especially in patients in the advanced stages. These results highlight the value of routinely checking serum hepatic proteins in clinical practice to predict the prognosis of patients with cancer cachexia.
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10.
Efficacy and safety of Shenbai Granules for recurrent colorectal adenoma: A multicenter randomized controlled trial.
Ni, M, Zhang, Y, Sun, Z, Zhou, Q, Xiao, J, Zhang, B, Lin, J, Gong, B, Liu, F, Meng, F, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2024;:155496
Abstract
BACKGROUND Colorectal adenoma is benign glandular tumor of colon, the precursor of colorectal cancer. But no pharmaceutical medication is currently available to treat and prevent adenomas. PURPOSE To evaluate efficacy of Shenbai Granules, an herbal medicine formula, in reducing the recurrence of adenomas. STUDY DESIGN This multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted by eight hospitals in China. METHODS Patients who had received complete polypectomy and were diagnosed with adenomas within the recent 6 months were randomly assigned (1:1) to receive either Shenbai granules or placebo twice a day for 6 months. An annual colonoscopy was performed during the 2-year follow-up period. The primary outcome was the proportion of patients with at least one adenoma detected in the modified intention-to-treat (mITT) population during follow-up for 2 years. The secondary outcomes were the proportion of patients with sessile serrated lesions and other specified polypoid lesions. The data were analyzed using logistic regression. RESULTS Among 400 randomized patients, 336 were included in the mITT population. We found significant differences between treatment and placebo groups in the proportion of patients with at least one recurrent adenoma (42.5 % vs. 58.6 %; OR, 0.47; 95 % CI, 0.29-0.74; p = 0.001) and sessile serrated lesion (1.8 % vs. 8.3 %; OR, 0.20; 95 % CI, 0.06-0.72; p = 0.01). There was no significant difference in the proportion of patients developing polypoid lesions (70.7 % vs. 77.5 %; OR, 1.43; 95 % CI, 0.88-2.34; p = 0.15) or high-risk adenomas (9.0 % vs. 13.6 %; OR, 0.63; 95 % CI, 0.32-1.25; p = 0.18). CONCLUSION Shenbai Granules significantly reduced the recurrence of adenomas, indicating that they could be an effective option for adenomas. Future studies should investigate its effects in larger patient populations and explore its mechanism of action to provide more comprehensive evidence for the use of Shenbai Granules in adenoma treatment.