Nevin Manimala

Trials. 2025 Feb 6;26(1):42. doi: 10.1186/s13063-025-08759-0.

ABSTRACT

BACKGROUND: The TARGET Protein trial will evaluate the effect of greater enteral protein delivery (augmented protein) on clinical outcomes of critically ill adult patients when compared to usual care.

OBJECTIVE: To describe the statistical analysis plan for the TARGET Protein trial.

METHODS: TARGET Protein is a cluster randomized, cross-sectional, double cross-over, open-label, registry-embedded, pragmatic clinical trial conducted across Australia and New Zealand. The trial randomized eight intensive care units (ICU) to receive enteral formula containing either higher dose enteral protein (augmented protein) or usual dose protein in a 1:1 ratio. Each ICU received one trial formula for a 3-month period and then switched to the alternate formulae. This sequence was repeated, for a total trial length of 12 months. The primary outcome is the number of days free of the index hospital and alive at day 90. Secondary outcomes include proportion of patients alive at day 90, survivor-only analysis of days free of the index hospital at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination. The statistical methods and models which will be used to estimate the effects for the primary and secondary outcomes are described. All statistical models will account for the cluster-randomized cross-over design to ensure correct estimation of the 95% confidence intervals. Trial enrolment is complete with 3412 patients enrolled. Data linkage is ongoing.

CONCLUSION: This statistical analysis plan enables transparent reporting of the TARGET Protein trial. It will reduce the risk of potential selective reporting biases.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.

PMID:39915843 | DOI:10.1186/s13063-025-08759-0

BMC Health Serv Res. 2025 Feb 6;25(1):214. doi: 10.1186/s12913-024-12164-9.

ABSTRACT

BACKGROUND: Individual psychosocial work characteristics have been associated with the health and well-being of registered nurses. However, it remains to be determined whether different types of psychosocial work characteristics form patterned profiles and whether the profiles are associated with registered nurses’ health and welfare at different stages of their careers. The purpose of this study was to identify latent psychosocial work characteristic profiles and examine whether the profiles are associated with a certain career stage and health outcomes.

METHODS: This cross-sectional study was conducted with 624 early-career registered nurses and 1,016 later-career registered nurses. Data were collected using an electronic survey with internationally validated measures including the Organizational Justice Scale, the Nurse Stress Index Scale, the Job Content Questionnaire, the Team Climate Inventory, the Psychological Distress Questionnaire, the Sleep Problems Questionnaire, and the Self-Rated Health Questionnaire. Latent profile analysis was conducted to identify subgroups with similar psychosocial work characteristic profiles. Multinomial and linear regression analyses were used to examine the association between latent work characteristics profiles, stage of career, and health outcomes.

RESULTS: We identified five profiles. The profiles were named based on class descriptions. The low strain/high support profile group and the moderate strain/high support profile group had statistically better self-rated health (p = < 0.001), less psychological distress (p = < 0.001) and less sleep problems (p = < 0.001) compared to the high strain/low support profile group.

CONCLUSIONS: Low to moderate strain, high interactional and procedural justice, and participative safety in teams form patterned profiles associated with better health in registered nurses. High strain, a lack of justice and a lack of participation safety form a risk combination pattern profile that may lead to health problems in registered nurses. Promoting procedural and interactional justice, and participation safety in teams seems efficient in enhancing the health and well-being of registered nurses. The findings indicate no significant correlation between career stages and work characteristic profiles. It is crucial to identify stressors specific for career stages and develop tailored interventions.

PMID:39915838 | DOI:10.1186/s12913-024-12164-9

Syst Rev. 2025 Feb 6;14(1):35. doi: 10.1186/s13643-025-02780-9.

NO ABSTRACT

PMID:39915835 | DOI:10.1186/s13643-025-02780-9

BMC Public Health. 2025 Feb 6;25(1):491. doi: 10.1186/s12889-024-21261-7.

ABSTRACT

BACKGROUND: Transgender, nonbinary, and gender diverse (TGD) people experience stigma in healthcare settings impacting healthcare utilization, including avoidance of care due to anticipated discrimination. Gender-affirming care refers to care for medical gender affirmation, such as gender-affirming hormones and surgery, as well as general care that affirms and respects TGD patients. This study sought to explore the experiences of TGD adults to inform gender-affirming care delivery and develop an actionable framework for practice.

METHODS: Between May-October 2021, one-time individual in-depth interviews were conducted with 27 TGD adults receiving any healthcare in the greater Boston Massachusetts area to gather data about gender-affirming care. Interviews were semi-structured, explored prior and current experiences in healthcare and ideal gender-affirming care models, and conducted virtually via a secure Zoom platform. Analyses were conducted using immersion crystallization and reflexive thematic analysis; interview transcripts were double coded by two coders.

RESULTS: Participants had a mean age of 28.5, ranging 18-45 years, and were: 7 transgender men, 6 transgender women, 8 nonbinary, 3 genderqueer, 1 agender, and 2 gender not specified. Themes about gender-affirming care coalesced into the acronym AFFIRM: (1) Affirms in individual interactions: Participants called for affirmation of TGD identity, lived expertise, and competent TGD providers and staff. (2) Flexible and accessible: Participants expressed the need for gender-affirming care to be available beyond urban population-specific clinics, in a timely fashion without long wait lists, and in a community-centered manner such as offering non-traditional times and settings. (3) Fights systemic oppression: Participants emphasized the need for providers and health systems to eliminate gatekeeping practices for gender-affirming care and create care models that resist intersecting oppressive systems such as racism and cisgenderism. (4) Interacts with community: Patients desired intentional interaction with TGD community to holistically address health and unmet gender affirmation needs. (5) Retains patients in care: Patients shared the need to collaboratively identify and problem-solve obstacles to gender-affirming care with providers and healthcare systems to optimize TGD-specific retention strategies. (6) Multidisciplinary: Patients called for interdisciplinary teams with co-located services such as primary care and mental healthcare with letter-writing for surgical care, and incorporation of peer navigators to meet the broader social, health, and well-being needs of TGD people.

CONCLUSIONS: Findings from this study and the AFFIRM Framework which emerged from TGD patient narratives can be applied to improve current care and set benchmarks for high-quality gender-affirming care delivery and practice.

PMID:39915834 | DOI:10.1186/s12889-024-21261-7

Cardiovasc Diabetol. 2025 Feb 6;24(1):55. doi: 10.1186/s12933-025-02610-1.

ABSTRACT

The stress hyperglycemia ratio (SHR) is an emerging biomarker used to assess blood glucose levels under acute stress conditions and has been linked to the incidence of adverse clinical outcomes. However, the precise role of SHR in patients with diabetic kidney disease (DKD) and chronic kidney disease (CKD), particularly in relation to mortality, remains poorly understood. This study seeks to investigate the clinical value of SHR as a predictive tool for all-cause and cardiovascular mortality in these patient groups. This study analyzed data from the National Health and Nutrition Examination Survey (NHANES) spanning from 1999 to 2018, encompassing 3,507 individuals diagnosed with diabetic kidney disease (DKD) or chronic kidney disease (CKD). The primary endpoints included all-cause mortality and cardiovascular mortality, with mortality data obtained from the National Death Index (NDI) through December 31, 2019. Participants were categorized into quartiles based on the stress hyperglycemia ratio (SHR), and Cox proportional hazards regression models were employed to examine the association between SHR and mortality. Model 1 did not account for any covariates, Model 2 adjusted for age, sex, and race, while Model 3 additionally incorporated adjustments for educational attainment, marital status, body mass index, smoking behavior, hypertension, hyperlipidemia, and cardiovascular disease. The study comprised 3,507 patients with a mean age of 60.7 years, of whom 56% were female. The overall incidence of all-cause mortality was 38,000 per 100,000 person-years, while cardiovascular mortality was 11,405 per 100,000 person-years. Kaplan-Meier survival analysis revealed that the second quartile of the stress hyperglycemia ratio (SHR) (Q2) exhibited the lowest all-cause mortality (log-rank P = 0.003). Cox regression analysis indicated that the hazard ratio (HR) for all-cause mortality in Q2 was 0.76 (95% CI: 0.63, 0.92), whereas the HR for Q4 was 1.26 (95% CI: 1.04, 1.52). Restricted cubic spline (RCS) analysis revealed a J-shaped association between SHR and all-cause mortality, as well as a U-shaped association with cardiovascular mortality. The minimum risk values for SHR were 0.923 for all-cause mortality and 1.026 for cardiovascular mortality. In patients with diabetic kidney disease (DKD) and chronic kidney disease (CKD), SHR demonstrated a J-shaped relationship with all-cause mortality and a U-shaped relationship with cardiovascular mortality. Subgroup analyses indicated that the effect of spontaneous hypertension on mortality was consistent across all subgroups. This study highlights a significant association between the stress hyperglycemia ratio (SHR) and both all-cause and cardiovascular mortality in patients with diabetic kidney disease (DKD) or chronic kidney disease (CKD). SHR may serve as a critical biomarker for prognostic assessment in these populations, enabling clinicians to identify high-risk patients and tailor personalized treatment strategies that enhance patient quality of life and mitigate mortality risk.

PMID:39915833 | DOI:10.1186/s12933-025-02610-1

BMC Musculoskelet Disord. 2025 Feb 7;26(1):127. doi: 10.1186/s12891-025-08379-4.

ABSTRACT

BACKGROUND: Work-related musculoskeletal disorders (WRMSDs) are significant concern in intensive care units (ICUs) due to distinct work environment. This study aims to comprehensively investigate determinants of WRMSDs and ergonomic challenges, specific to ICU nurses, providing valuable insights for targeted interventions.

METHODS: In this six-month convergent mixed methods study, 200 consenting nurses with over one year of experience from seven ICUs across three public tertiary hospitals of Ahmedabad participated. Structured questionnaires were used to collect data on socio-demographics, occupation, physical and workplace factors, risk perception, and musculoskeletal pain (through modified Nordic Musculoskeletal Questionnaire) and ergonomic issues using REBA (Rapid Entire Body Assessment) scale. Qualitative insights were obtained through in-depth interviews until saturation of responses. Statistical analysis involved chi-square, t-test and logistic regression, with a significance level set at p < 0.05. Thematic analysis was used to interpret the findings of qualitative study.

RESULTS: The study included predominantly female ICU nurses (78%) with a mean age of 34 years. A high prevalence of WRMSDs (84%) was observed, with the lower back and neck being the most affected regions. Nurses with WRMSDs reported significantly higher mean scores for physical factors (15.1 vs. 11.1, p = 0.00), physical workload (12.8 vs. 10.7, p = 0.001), work environment (13.1 vs. 10.1, p = 0.00), and risk perception (11.8 vs. 8.9, p = 0.00) compared to those without WRMSDs. Logistic regression identified key risk factors for WRMSDs, including longer ICU tenure [OR = 1.4 (1.13-1.66)], high shift frequency [OR = 2.7 (1.27-5.95)], higher physical factor score [OR = 1.2 (1.05-1.42)], higher physical workload score [OR = 1.2 (1.09-1.49)], higher risk perception [OR = 1.3 (1.10-1.78)], and lack of exercise [OR = 0.5 (0.27-0.93)]. The qualitative findings highlighted key ergonomic challenges, including inadequate equipment, heavy patient loads, poor posture during tasks, and insufficient breaks, contributing to WRMSDs among ICU nurses.

CONCLUSION: The findings underscore urgent need for targeted interventions to address risk factors associated with WRMSDs, including ergonomic training, workplace modifications, and education programs to enhance risk awareness and preventive behaviours. Future research should focus on developing and evaluating comprehensive interventions that integrate both physical and work environment factors to effectively mitigate WRMSDs among ICU nurses.

PMID:39915824 | DOI:10.1186/s12891-025-08379-4

Reprod Biol Endocrinol. 2025 Feb 6;23(1):20. doi: 10.1186/s12958-025-01354-7.

ABSTRACT

BACKGROUND: Previous studies have shown that due to the presence of endometrium progesterone resistance in patients with endometriosis, it is considered that higher levels of progesterone may be required to achieve live birth during programmed frozen-thawed embryo transfer (FET) cycles. Currently, the optimal progesterone support in FET cycles remains a contentious issue, and it mainly focused on the general infertile population, without specific attention to infertile patients with endometriosis. This study aimed to compare the pregnancy outcomes between vaginal or intramuscular progesterone administration in patients with endometriosis, and to determine whether the stage of endometriosis moderates the differences.

METHODS: This retrospective cohort study included patients with endometriosis who underwent their first single frozen-thawed blastocyst transfer in a programmed cycle from January 2018 to April 2024 at a university-affiliated reproductive medical center. According to the routes of luteal support, patients were divided into vaginal progesterone and intramuscular progesterone groups. Analyses were conducted using multivariate regression models and subgroup analysis. Interaction tests were employed to determine whether the revised American Society for Reproductive Medicine (r-ASRM) stages of endometriosis moderated the differences between the routes of progesterone administration and pregnancy outcomes.

RESULTS: A total of 825 programmed frozen-thawed blastocyst transfer cycles were included in the analysis, with 362 cases using vaginal progesterone and 463 cases using intramuscular progesterone. In the overall cohort, clinical pregnancy rate of the vaginal progesterone group was 49.17%, comparable to 44.06% of the intramuscular progesterone group (aOR 0.82, 95% CI 0.61-1.11). Similarly, there was no statistically significant difference in miscarriage rates between the two groups (16.85% versus 24.51%; aOR 1.57, 95% CI 0.90-2.75). In the subgroup analysis in patients classified as r-ASRM stages I-II, clinical pregnancy rate of vaginal progesterone group was significantly higher than that of intramuscular group (aOR 0.74, 95% CI 0.58-0.93, P = 0.011). Whereas, in patients with stages III-IV, no significant differences in pregnancy outcomes between the two groups were detected. Interaction tests between the routes of progesterone administration and r-ASRM stages were significant (P = 0.036).

CONCLUSIONS: In the first single frozen-thawed blastocyst transfer cycles for endometriosis patients with r-ASRM stages I-II, vaginal progesterone favours a higher clinical pregnancy rate compared to the intramuscular progesterone.

PMID:39915817 | DOI:10.1186/s12958-025-01354-7

BMC Pulm Med. 2025 Feb 6;25(1):63. doi: 10.1186/s12890-025-03509-z.

ABSTRACT

BACKGROUND: While clinical trials have demonstrated enduring responses to amivantamab among advanced non-small cell lung cancer (NSCLC) patients bearing EGFR exon 20 insertion mutations, the associated toxicity profile in real-world scenarios remains elusive.

METHODS: This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) to investigate adverse events associated with amivantamab over the period from September 2021 to December 2023. A comprehensive disproportionality analysis was performed, employing the reporting odds ratio (ROR), proportional reporting ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and the Bayesian confidence propagation neural network to calculate information components (ICs), to identify statistically significant adverse events.

RESULTS: A significant proportion of adverse events (AEs) was attributable to injury, poisoning, and procedural complications, cutaneous disorders, respiratory ailments, infections, as well as vascular and lymphatic system disturbances. There were noteworthy incidences of AEs including infusion-related reactions, rash, dyspnea, pneumonitis, paronychia, pulmonary embolism, thrombocytopenia, nausea, acneiform dermatitis, deep vein thrombosis, febrile neutropenia, peripheral edema, hypokalemia, and neutropenia. Furthermore, the majority of AEs occurred within the first month following the initiation of amivantamab treatment, accounting for 51.74% of cases.

CONCLUSION: The reversibility of amivantamab-related toxicities suggests its promising utility in patients with EGFR exon 20 insertion mutations NSCLC.

PMID:39915804 | DOI:10.1186/s12890-025-03509-z

BMC Public Health. 2025 Feb 6;25(1):497. doi: 10.1186/s12889-025-21734-3.

ABSTRACT

BACKGROUND: Muscle quality index (MQI), an emerging health index, is calculated by dividing handgrip strength by skeletal muscle mass. Current evidence on the correlation between MQI and type 2 diabetes mellitus (T2DM), insulin resistance (IR) is limited. This work aims to study that correlation.

METHODS: This study involves a cross-sectional analysis on data from the National Health and Nutrition Examination Survey (NHANES) during the period from 2011 to 2014. To explore the correlation between MQI, IR and T2DM, multivariate logistic regression, receiver operating characteristic (ROC) curve, subgroup analysis, and restricted cubic spline regression were employed.

RESULTS: A total of 2816 American adults were enrolled in this study, among whom 1264 (44.9%) had IR, and 300 (10.7%) had T2DM. Logistic regression and RCS regression analyses showed a significant negative linearly correlation between MQI and the prevalence of IR (OR = 0.708, 95%=0.514, 0.976) and T2DM (OR = 0.676, 95%CI = 0.472, 0.969). Subgroup analysis further revealed a stronger correlation between MQI and IR among individuals with obesity. ROC analysis showed that compared with skeletal muscle and grip strength, MQI (AUC = 0.679 for IR and 0.688 for T2DM) can serve as a more reliable identification factor for IR and T2DM.

CONCLUSION: This study provides evidence that decreased levels of MQI are correlated with an increased risk of IR and T2DM, indicating the potential utility as a marker for identifying IR and T2DM.

PMID:39915803 | DOI:10.1186/s12889-025-21734-3

BMC Med Educ. 2025 Feb 6;25(1):196. doi: 10.1186/s12909-025-06765-z.

ABSTRACT

BACKGROUND: The number of deaths in the United States attributed to overdose was 70,237 in 2017 and 67,367 in 2018. Approximately 67.7% and 69.5%, respectively, of these deaths involved the use of opioids. Moreover, different specialties of physicians often have different experiences and encounters with people involved with opioids. To investigate medical students’ beliefs about the opioid crisis and their post-graduation plans from two medical schools in the United States.

METHODS: 312 students from one medical school with three campuses were surveyed on their experiences, beliefs, and the impacts that the opioid crisis has had on their lives and their medical training. T-tests compared the difference in confidence and expectations to treat people with opioid addiction. Qualitative data was also analyzed from participants’ comments pertaining to the opioid crisis. A proportion test was performed to compare the percentage of students pursuing primary care for those immediately impacted by opioids. P < 0.05 defined statistical significance for all statistical tests performed in this study.

RESULTS: Approximately 39.7% of medical students surveyed were planning to pursue primary care, and 60.3% were planning to pursue any of the other specialties. The two-sample proportion test did not show a statistically significant difference in the percentage of students pursuing primary care for those immediately impacted and those not (P = 0.9, α = 0.05). The t-test comparing the expectation to treat people with opioid addiction did not show a statistically significant difference between students (P = 0.9, α = 0.05). Students wanting to pursue specialties outside of primary care were significantly more confident in treating people with opioid addiction (P < 0.01, α = 0.05).

CONCLUSION: This study was conducted to identify the differences in perspective of medical students planning to pursue varying specialties. The findings of this study show a disparity in confidence levels for treating people with opioid use disorder between specialties. The knowledge gained in this study can help to inform medical school curriculum design to ensure that all students feel confident and prepared to treat those with opioid use disorder.

PMID:39915797 | DOI:10.1186/s12909-025-06765-z