Nevin Manimala

JAMA. 2024 May 19. doi: 10.1001/jama.2024.8693. Online ahead of print.

ABSTRACT

IMPORTANCE: Current treatments for idiopathic pulmonary fibrosis slow the rate of lung function decline, but may be associated with adverse events that affect medication adherence. In phase 2 trials, pamrevlumab (a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity) attenuated the progression of idiopathic pulmonary fibrosis without substantial adverse events.

OBJECTIVE: To assess the efficacy and safety of pamrevlumab for patients with idiopathic pulmonary fibrosis.

DESIGN, SETTING, AND PARTICIPANTS: Phase 3 randomized clinical trial including 356 patients aged 40 to 85 years with idiopathic pulmonary fibrosis who were not receiving antifibrotic treatment with nintedanib or pirfenidone at enrollment. Patients were recruited from 117 sites in 9 countries between July 18, 2019, and July 29, 2022; the last follow-up encounter occurred on August 28, 2023.

INTERVENTIONS: Pamrevlumab (30 mg/kg administered intravenously every 3 weeks; n = 181) or placebo (n = 175) for 48 weeks.

MAIN OUTCOMES AND MEASURES: The primary outcome was absolute change in forced vital capacity (FVC) from baseline to week 48. There were 5 secondary outcomes (including time to disease progression, which was defined as a decline of ≥10% in predicted FVC or death). The exploratory outcomes included patient-reported symptoms. Adverse events were reported.

RESULTS: Among 356 patients (mean age, 70.5 years; 258 [72.5%] were men; 221 [62.1%] were White), 277 (77.8%) completed the trial. There was no significant between-group difference for absolute change in FVC from baseline to week 48 (least-squares mean, -260 mL [95% CI, -350 to -170 mL] in the pamrevlumab group vs -330 mL [95% CI, -430 to -230 mL] in the placebo group; mean between-group difference, 70 mL [95% CI, -60 to 190 mL], P = .29). There were no significant between-group differences in any of the secondary outcomes or in the patient-reported outcomes. In the pamrevlumab group, there were 160 patients (88.4%) with treatment-related adverse events and 51 patients (28.2%) with serious adverse events vs 151 (86.3%) and 60 (34.3%), respectively, in the placebo group. During the study, 23 patients died in each group (12.7% in the pamrevlumab group vs 13.1% in the placebo group).

CONCLUSIONS AND RELEVANCE: Among patients with idiopathic pulmonary fibrosis treated with pamrevlumab or placebo, there was no statistically significant between-group difference for the primary outcome of absolute change in FVC from baseline to week 48.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03955146.

PMID:38762797 | DOI:10.1001/jama.2024.8693

Semin Ophthalmol. 2024 May 19:1-5. doi: 10.1080/08820538.2024.2354692. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the incidence and cost of intraocular lens(IOL) waste during IOL implantation, as well as the reasons for it.

METHODS: A retrospective analysis was conducted on the data of 485 patients from the IOL waste registers of a single tertiary eye hospital in China during 2016-2020. The primary outcomes were the incidence, cost, and reasons for different IOL properties. Cases were examined to ascertain IOL material, design, procedural details, and causes of waste.

RESULTS: IOL waste occurred in 485 (6.62‰) of the 73,246 IOL implantations during the study period. The total cost of IOL waste was 429, 850.26 Chinese Yuan (CNY) related to waste with an average cost of 2, 442.33 CNY per procedure during the study period. Comparisons between IOL properties showed that polymethyl methacrylate (PMMA) material (39, 2.05%), three-piece design (142, 1.49%), and secondary IOL implantation (26, 2.16%) were associated with IOL wastage, and the difference was statistically significant. The causes of IOL waste were damage (107, 60.80%), patient reasons (37, 21.26%), aseptic errors (22, 12.50%), IOL quality problems (8, 4.55%), and loss (2, 1.14%).

CONCLUSIONS: The incidence of IOL waste is low, but still leads to a significant cost burden due to a large number of cataract surgeries. PMMA material, three-piece design, and secondary implantation were identified as factors increasing IOL waste. Damage emerged as the primary reason for waste, largely attributed to human error. Therefore, the development of strategies to mitigate IOL waste is imperative.

PMID:38762793 | DOI:10.1080/08820538.2024.2354692

Am J Reprod Immunol. 2024 May;91(5):e13858. doi: 10.1111/aji.13858.

ABSTRACT

PROBLEM: In the current study we aimed to investigate Syndecan 1 (SDC1) levels in pregnant women diagnosed with fetal growth restriction (FGR) and the relationship between SDC1 levels and clinical and doppler parameters in FGR cases associated with endothelial dysfunction, angiogenesis and uteroplacental insufficiency METHOD OF STUDY: A total of 90 pregnant women included in the study, (45 with FGR, 45 healthy control) matched by week of gestation and maternal age. Venous blood samples were collected and plasma concentrations of SDC1 were determined by a specific immunoassay. Doppler examination was performed to evaluate the relationship between the SDC1 levels and placental blood supply.

RESULTS: Doppler parameters; mean UtA-PI (p < .001), CPR (p = .002) and CPUR (p < .001) were different between the groups, however MCA PI, umbilical artery PI and umbilical artery S/D were not (p > .05). While gestational age at delivery, birth weight, APGAR score at 1 and 5 min were significantly lower (all, p < .001) in the study group, non-reassure fetal heart rate tracing (p = .09) and NICU admission (p = .02) were significantly higher. SDC 1 level was 2,00 ± 1,47 ng/mL and 2,34 ± 1,12 ng/mL in the FGR and control groups, respectively (p = .008). In the study group SDC 1 level was 1,69 ± 2,00 in those with gestational age below 32 weeks and 2,13 ± 1,18 in those with gestational age above 32 weeks and there was a statistically significant difference between the groups (p = .015). Plasma SDC 1 concentration of 2,1850 ng/mL or less had a sensitivity of 70%, a specificity of 72%, area under the ROC curve .65 (p < .005).

CONCLUSIONS: Low maternal plasma SDC1 level may be associated with placental insufficiency and FGR. Low levels of SDC1 may be helpful as a predictor for the development of FGR during gestation.

PMID:38762781 | DOI:10.1111/aji.13858

Clin Gerontol. 2024 May 19:1-11. doi: 10.1080/07317115.2024.2346906. Online ahead of print.

ABSTRACT

OBJECTIVES: To describe nursing home (NH) characteristics associated with antipsychotic use and test whether associations changed after implementation of the National Partnership to Improve Dementia Care’s antipsychotic reduction initiative (ARI).

METHODS: Longitudinal quasi-experimental design using data from multiple sources and piecewise linear mixed models were used for statistical analyses.

RESULTS: There was a significant decrease in monthly antipsychotic use across the study period (pre-ARI b = -0.0003, p <.001; post-ARI b = -0.0012, p <.001), which held after adjusting for NH characteristics. Registered nurse hours (b = -0.0026, p <.001), licensed practical nurse hours (b = -0.0019, p <.001), facility chain membership (b = -0.0013, p <.01), and health inspection ratings (b = -0.0003, p >.01) were associated with decreased antipsychotic use. Post-ARI changes in associations between NH characteristics and antipsychotic use were small and not statistically significant.

CONCLUSIONS: Decreases in antipsychotic use were associated with most NH characteristics, and associations persisted post-ARI. Further research is warranted to examine the interactions between ARI policy and NH characteristics on antipsychotic prescribing, as well as other NH factors, such as facility prescribing cultures and clinical specialty of staff.

CLINICAL IMPLICATIONS: Decreases in monthly antipsychotic use were observed following the ARI. The decreases in monthly antipsychotic use were associated with most NH characteristics, and these associations persisted during the post-ARI period.

PMID:38762776 | DOI:10.1080/07317115.2024.2346906

Med Sci Monit. 2024 May 19;30:e944553. doi: 10.12659/MSM.944553.

ABSTRACT

BACKGROUND Scaphoid nonunion (SN) is a challenging condition in wrist pathology, often resulting in severe consequences if left untreated. Surgical intervention, particularly using vascularized bone grafts (VBGs), is a promising but uncertain approach. The 4+5 extensor compartment artery (ECA) pedicled graft, less commonly used for SN, has potential benefits due to its vascular supply and accessibility to the scaphoid. This study aimed to evaluate the effectiveness of the 4+5 ECA pedicled graft combined with headless compression screw fixation in treating avascular necrosis (AVN)-induced proximal pole SN. Radiological results, functional outcomes, and complications related to this method were assessed. MATERIAL AND METHODS This was a retrospective analysis of 19 proximal pole SN cases with AVN treated using the 4+5 ECA-VBG technique from 2016 to 2022. Patients underwent preoperative evaluation and postoperative follow-up for at least 1 year. Data on surgery, demographics, radiological assessments, and functional outcomes were recorded and analyzed statistically. RESULTS All patients achieved radiographic union within 8.5 weeks postoperatively, with revascularization of proximal pole necrosis. Significant improvements in functional outcomes were observed, including pain reduction, increased wrist range of motion, improved grip and pinch strength, and enhanced wrist scores. No major complications were reported. CONCLUSIONS The 4+5 ECA-VBG technique, with headless compression screw fixation, showed high success rates in treating AVN-induced proximal pole SN. This method offers comprehensive restoration of wrist function and minimal complications, making it a viable option for SN management, especially in AVN cases. Further research is needed to confirm these results and establish standardized protocols for SN treatment.

PMID:38762751 | DOI:10.12659/MSM.944553

Autophagy. 2024 May 18:1-8. doi: 10.1080/15548627.2024.2353458. Online ahead of print.

ABSTRACT

Segmenting autophagic bodies in yeast TEM images is a key technique for measuring changes in autophagosome size and number in order to better understand macroautophagy/autophagy. Manual segmentation of these images can be very time consuming, particularly because hundreds of images are needed for accurate measurements. Here we describe a validated Cellpose 2.0 model that can segment these images with accuracy comparable to that of human experts. This model can be used for fully automated segmentation, eliminating the need for manual body outlining, or for model-assisted segmentation, which allows human oversight but is still five times as fast as the current manual method. The model is specific to segmentation of autophagic bodies in yeast TEM images, but researchers working in other systems can use a similar process to generate their own Cellpose 2.0 models to attempt automated segmentations. Our model and instructions for its use are presented here for the autophagy community.Abbreviations: AB, autophagic body; AvP, average precision; GUI, graphical user interface; IoU, intersection over union; MVB, multivesicular body; ROI, region of interest; TEM, transmission electron microscopy; WT,wild type.

PMID:38762750 | DOI:10.1080/15548627.2024.2353458

Crit Care. 2024 May 18;28(1):168. doi: 10.1186/s13054-024-04955-7.

ABSTRACT

BACKGROUND: Critically injured patients need rapid and appropriate hemostatic treatment, which requires prompt identification of trauma-induced coagulopathy (TIC) upon hospital admission. We developed and validated the performance of a clinical score based on prehospital resuscitation parameters and vital signs at hospital admission for early diagnosis of TIC.

METHODS: The score was derived from a level-1 trauma center registry (training set). It was then validated on data from two other level-1 trauma centers: first on a trauma registry (retrospective validation set), and then on a prospective cohort (prospective validation set). TIC was defined as a PT_ratio > 1.2 at hospital admission. Prehospital (vital signs and resuscitation care) and admission data (vital signs and laboratory parameters) were collected. We considered parameters independently associated with TIC in the score (binomial logistic regression). We estimated the score’s performance for the prediction of TIC.

RESULTS: A total of 3489 patients were included, and among these a TIC was observed in 22% (95% CI 21-24%) of cases. Five criteria were identified and included in the TIC Score: Glasgow coma scale < 9, Shock Index > 0.9, hemoglobin < 11 g.dL^-1, prehospital fluid volume > 1000 ml, and prehospital use of norepinephrine (yes/no). The score, ranging from 0 and 9 points, had good performance for the identification of TIC (AUC: 0.82, 95% CI: 0.81-0.84) without differences between the three sets used. A score value < 2 had a negative predictive value of 93% and was selected to rule-out TIC. Conversely, a score value ≥ 6 had a positive predictive value of 92% and was selected to indicate TIC.

CONCLUSION: The TIC Score is quick and easy to calculate and can accurately identify patients with TIC upon hospital admission.

PMID:38762746 | DOI:10.1186/s13054-024-04955-7

BMC Public Health. 2024 May 18;24(1):1348. doi: 10.1186/s12889-024-18806-1.

ABSTRACT

AIM: Understanding vaccine hesitancy, as a critical concern for public health, cannot occur without the use of validated measures applicable and relevant to the samples they are assessing. The current study aimed to validate the Vaccine Hesitancy Scale (VHS) and to investigate the predictors of children’s vaccine hesitancy among parents from Australia, China, Iran, and Turkey. To ensure the high quality of the present observational study the STROBE checklist was utilized.

DESIGN: A cross-sectional study.

METHOD: In total, 6,073 parent participants completed the web-based survey between 8 August 2021 and 1 October 2021. The content and construct validity of the Vaccine Hesitancy Scale was assessed. Cronbach’s alpha and McDonald’s omega were used to assess the scale’s internal consistency, composite reliability (C.R.) and maximal reliability (MaxR) were used to assess the construct reliability. Multiple linear regression was used to predict parental vaccine hesitancy from gender, social media activity, and perceived financial well-being.

RESULTS: The results found that the VHS had a two-factor structure (i.e., lack of confidence and risk) and a total of 9 items. The measure showed metric invariance across four very different countries/cultures, showed evidence of good reliability, and showed evidence of validity. As expected, analyses indicated that parental vaccine hesitancy was higher in people who identify as female, more affluent, and more active on social media.

CONCLUSIONS: The present research marks one of the first studies to evaluate vaccine hesitancy in multiple countries that demonstrated VHS validity and reliability. Findings from this study have implications for future research examining vaccine hesitancy and vaccine-preventable diseases and community health nurses.

PMID:38762744 | DOI:10.1186/s12889-024-18806-1

Nutr J. 2024 May 18;23(1):55. doi: 10.1186/s12937-024-00955-z.

ABSTRACT

BACKGROUND: Assessing the trends in dietary GHGE considering the social patterning is critical for understanding the role that food systems have played and will play in global emissions in countries of the global south. Our aim is to describe dietary greenhouse gas emissions (GHGE) trends (overall and by food group) using data from household food purchase surveys from 1989 to 2020 in Mexico, overall and by education levels and urbanicity.

METHODS: We used cross-sectional data from 16 rounds of Mexico’s National Income and Expenditure Survey, a nationally representative survey. The sample size ranged from 11,051 in 1989 to 88,398 in 2020. We estimated the mean total GHGE per adult-equivalent per day (kg CO2-eq/ad-eq/d) for every survey year. Then, we estimated the relative GHGE contribution by food group for each household. These same analyses were conducted stratifying by education and urbanicity.

RESULTS: The mean total GHGE increased from 3.70 (95%CI: 3.57, 3.82) to 4.90 (95% CI 4.62, 5.18) kg CO2-eq/ad-eq/d between 1989 and 2014 and stayed stable between 4.63 (95% CI: 4.53, 4.72) and 4.89 (95% CI: 4.81, 4.96) kg CO2-eq/ad-eq/d from 2016 onwards. In 1989, beef (19.89%, 95% CI: 19.18, 20.59), dairy (16.87%, 95% CI: 16.30, 17.42)), corn (9.61%, 95% CI: 9.00, 10.22), legumes (7.03%, 95% CI: 6.59, 7.46), and beverages (6.99%, 95% CI: 6.66, 7.32) had the highest relative contribution to food GHGE; by 2020, beef was the top contributor (17.68%, 95%CI: 17.46, 17.89) followed by fast food (14.17%, 95% CI: 13.90, 14.43), dairy (11.21%, 95%CI: 11.06, 11.36), beverages (10.09%, 95%CI: 9.94, 10.23), and chicken (10.04%, 95%CI: 9.90, 10.17). Households with higher education levels and those in more urbanized areas contributed more to dietary GHGE across the full period. However, households with lower education levels and those in rural areas had the highest increase in these emissions from 1989 to 2020.

CONCLUSIONS: Our results provide insights into the food groups in which the 2023 Mexican Dietary Guidelines may require to focus on improving human and planetary health.

PMID:38762743 | DOI:10.1186/s12937-024-00955-z

BMC Surg. 2024 May 18;24(1):162. doi: 10.1186/s12893-024-02440-0.

ABSTRACT

OBJECTIVES: To compare the efficacy of nadroparin and fondaparinux sodium for prevention of deep vein thromboembolism (DVT) in lower extremities after total hip arthroplasty (THA) and total knee arthroplasty (TKA).

METHODS: A total of 592 patients were enrolled in the study. Clinical data of patients who underwent total hip arthroplasty (THA) and total knee arthroplasty (TKA) in our hospital from December 2021 to September 2022 were retrospectively collected, which mainly included patients’ general information, surgery-related information, and DVT-related information. The patients were categorized into the nadroparin group(n = 278) and the fondaparinux sodium group(n = 314) according to the types of anticoagulants used. Anticoagulant therapy began 12-24 h after operation and continued until discharge. DVT prevalence between two groups was compared. The Statistical Package for Social Sciences (SPSS) software version 25 (SPSS, Armonk, NY, USA) was used for statistical analysis.

RESULTS: The prevalence of DVT in the nadroparin group and the fondaparinux sodium group was 8.3% (23/278) and 15.0% (47/314), respectively(p = 0.012). Statistical analysis showed that nadroparin group showed a lower prevalence of thrombosis than fondaparinux group (OR = 1.952, P = 0.012). Subgroup analyses showed that nadroparin group had a lower prevalence of DVT than fondaparinux group in some special patients groups such as female patients (OR = 2.258, P = 0.007), patients who are 65-79 years old (OR = 2.796, P = 0.004), patients with hypertension (OR = 2.237, P = 0.042), patients who underwent TKA (OR = 2.091, P = 0.011), and patients who underwent combined spinal-epidural anesthesia (OR = 2.490, P = 0.003) (P < 0.05).

CONCLUSION: Nadroparin may have an advantage over fondaparinux sodium in preventing DVT in lower extremities after THA and TKA.

PMID:38762739 | DOI:10.1186/s12893-024-02440-0