Tag: statistics

Lasers Surg Med. 2025 Feb 14. doi: 10.1002/lsm.23879. Online ahead of print.

ABSTRACT

BACKGROUND: Both nonablative fractional (NAFL) laser combined with intense pulsed light (IPL) and picosecond alexandrite laser (PSAL) with diffractive lens array (DLA) have been documented for their efficacy in facial rejuvenation.

OBJECTIVE: To observe the safety and efficacy of PSAL-DLA and IPL-NAFL in the rejuvenation of Chinese individuals.

METHODS: Each subject (n = 18) received three treatments on half of their face, with 1-month interval between treatments. One side of the face was randomly treated with PSAL-DLA, and the other side with IPL-NAFL. Quantitative data of wrinkles, pores, brown spots, and red areas were calculated using the VISIA-CR imaging system 3 months after the final treatment. Secondary outcomes included a 10-point VAS for patient-rated pain sensation, incidence of post-inflammatory hyperpigmentation (PIH), erythema and edema, and overall satisfaction. Adverse events were recorded after each treatment and at each follow-up.

RESULTS: A total of 17 Chinese female patients aged 28.2 ± 4.3 years completed the study and the 3-month follow-up. The IPL-NAFL side showed a statistically significant improvement in pores compared to baseline (p < 0.05); the PSAL-DLA side showed a statistically significant improvement in brown spots compared to baseline (p < 0.01). Compared to PSAL-DLA, the improvement in enlarged pores was better for IPL-NAFL (81.8 ± 128.1 vs. 20.8 ± 132.4, p < 0.01). In terms of pain, IPL-NAFL was more painful than PSAL-DLA (6 ± 1 vs. 4 ± 1, p < 0.01), a longer recovery time for erythema and edema (5 ± 1 vs. 2 ± 1, p < 0.001), and a higher incidence of PIH (58.8% vs. 23.5%, p < 0.05). Patient satisfaction was higher for PSAL-DLA than for IPL-NAFL (3 ± 1 vs. 4 ± 0.5, p < 0.01).

CONCLUSION: Our study results indicated that both IPL-NAFL and PSAL-DLA could improve the photoaging, but within the same number of treatments, IPL-NAFL was slightly more effective for enlarged pores than PSAL-DLA, while PSAL-DLA was more effective for brown spots than IPL-NAFL. Patients were more satisfied with PSAL-DLA, with a shorter postoperative recovery period and a lower incidence of PIH.

PMID:39950332 | DOI:10.1002/lsm.23879

Stat Med. 2025 Feb 28;44(5):e70024. doi: 10.1002/sim.70024.

ABSTRACT

Making good decisions about whether to commit-to-phase 3 clinical trials is challenging. This is especially true in oncology because the relationships between the registration endpoint, overall survival, and endpoints such as progression-free survival and confirmed objective response are often poorly understood. We present a framework for decision-making based on a three-endpoint win odds. We discuss properties of the win odds and suggest that it can be interpreted, for decision-making, as the reciprocal of an average hazard ratio for overall survival. We confirm the performance of the decision-making method using simulation studies and a clinical trial case study. As part of this work, we describe the simulation of correlated patient-level oncology endpoints using a multi-state model of disease. This model can provide clinically realistic data for testing the performance of analysis methods. We conclude that the win odds can improve commit-to-phase-3 decision-making compared with other methods.

PMID:39950312 | DOI:10.1002/sim.70024

Disaster Med Public Health Prep. 2025 Feb 14;19:e33. doi: 10.1017/dmp.2025.34.

ABSTRACT

OBJECTIVE: The ongoing conflict in Gaza, intensified since October 2023, has critically disrupted mental health services, exacerbating issues such as post-traumatic stress disorder (PTSD), anxiety, and depression among the population. This systematic review aims to identify and assess the challenges faced in mental health rehabilitation during this period.

METHODS: Utilizing the Arksey & O’Malley framework and PRISMA guidelines, a comprehensive literature search was conducted across 6 databases. Studies focusing on barriers to mental health services for Gazan residents were selected, and data were extracted using the Critical Appraisal Skills Program (CASP) for quality assessment.

RESULTS: Eight studies were included, revealing significant barriers to accessing mental health services, including extensive damage to health care infrastructure, a shortage of trained professionals, economic hardships, and a pervasive distrust in health care institutions.

CONCLUSIONS: The findings underscore the urgent need for tailored interventions and strategies to enhance access to mental health services and rebuild trust within the community. Addressing these barriers is essential for effective psychological rehabilitation and long-term recovery for the affected population in Gaza.

PMID:39950297 | DOI:10.1017/dmp.2025.34

Recent Adv Inflamm Allergy Drug Discov. 2025 Feb 7. doi: 10.2174/0127722708323777250121224618. Online ahead of print.

ABSTRACT

BACKGROUND: Type 1 diabetes mellitus (T1DM) is an autoimmune disease with difficult management, affecting the quality of life. Stem cell therapy has been proven to have regenerative ability. Using the existing stem cell therapy and modifying it, the current study aims to evaluate the effect of umbilical cord-derived mesenchymal stem cells (UCMSC), condition media (CM), and UCMSC and CM preconditioned with methotrexate, reservetrol, and vitamin D for its ability to manage T1DM in Swiss albino mice.

MATERIALS & METHODS: Disease condition was established in the animals by using a diabetesinducing agent streptozotocin (STZ). Then the animals were grouped into normal control, disease control, standard, and test groups; and the treatments were given accordingly. The total study period for this experiment was 28 days. During this period, the animals were supervised for blood glucose levels, food-water intake, and body weight twice a week. At the end of 28 days, the biochemical estimations for serum insulin level, C-peptide, pro-inflammatory cytokines, and anti-inflammatory cytokines level were done. Also, histopathology of the pancreas was performed.

RESULTS: The test groups showed a significant decline in the blood glucose level, an increase in C-peptide level, and a decrease in pro-inflammatory cytokines as compared to the disease group. A statistically significant change was not observed within the groups in terms of serum insulin and anti-inflammatory cytokine levels. There were improvements in diabetic symptoms in treatment groups, such as polyphagia, polydipsia, and weight loss. Treatment groups also showed pancreatic regeneration, indicating improved insulin secretion.

CONCLUSION: In the present study, we concluded that UCMSC, CM, and UCMSC and CM preconditioned with synthetic and natural immunosuppressants and immunomodulators have the ability to regenerate damaged pancreatic beta cells and have an antidiabetic activity, along with an immunomodulating effect. This therapy is a promising choice for future research.

PMID:39950288 | DOI:10.2174/0127722708323777250121224618

Pharmacoepidemiol Drug Saf. 2025 Feb;34(2):e70118. doi: 10.1002/pds.70118.

ABSTRACT

PURPOSE: Hip fractures in older adults cause severe pain that often necessitates opioid use. However, opioids may trigger falls that result in subsequent fractures. Studies examining the effects of opioids on subsequent fractures are often limited by unmeasured confounding between opioid-treated and untreated persons. To overcome this limitation, we used a self-controlled case series (SCCS) design to investigate subsequent fracture risk during periods of opioid use after hip fracture.

METHODS: The retrospective cohort included Medicare beneficiaries aged > 65 years who had a subsequent hip fracture within one year after an incident hip fracture (2012-2018). We estimated the risk of subsequent hip fracture in three exposure intervals according to the duration of opioid exposure: (1) The first 0-14 days of opioid exposure, (2) days 15-42 of exposure, and (3) opioid use beyond 42 days. We employed several approaches to modify the SCCS design to be more robust to assumptions, including adjustment for event-dependent exposures.

RESULTS: The rate of subsequent fracture was greatest during opioid use across a variety of approaches. The effect within the first 14 days after initiating opioids was robust to SCCS design choices, ranging from IRR 1.12 (95%CLs 0.98, 1.28) to IRR 1.77 (95%CLs 1.52, 2.07). The effect of extended opioid use (> 42 days) ranged from IRR 2.49 (95%CLs 1.95, 3.18) to IRR 4.08 (95%CLs 3.06, 5.46).

CONCLUSIONS: Analyses indicate a consistent increased risk of subsequent fracture associated with opioid use and demonstrate the importance that SCCS assumptions must be carefully investigated for real-world applications.

PMID:39950251 | DOI:10.1002/pds.70118

Pharmacoepidemiol Drug Saf. 2025 Feb;34(2):e70114. doi: 10.1002/pds.70114.

ABSTRACT

PURPOSE: To analyze the geographic and temporal patterns of biologic prescriptions for inflammatory bowel disease (IBD) in Brazil’s public national unified health system (SUS).

METHODS: This ecological study used data from patients with IBD in the SUS Outpatient Information System between 2008 and 2022. Prais-Winsten regression was used to estimate the trends in prescription rate of biologics. For geographic analysis, average prescription rate of biologics was calculated by state for three periods: 2008-2012, 2013-2017, and 2018-2022. Global Moran’s index (GMI) and local indicators of spatial autocorrelation (LISA) were used to assess spatial autocorrelation and identify spatial clusters of biologic prescriptions, respectively.

RESULTS: The prescription rate of biologics increased from 3.0% to 16.7%. Infliximab was the most prescribed drug from 2008 to 2012 (3.0%-4.2%), and adalimumab was the most widely prescribed drug from 2013 to 2022 (4.3%-9.1%). Higher prescription rates of biologics were observed in patients with Crohn’s disease than in those with ulcerative colitis (40.5% vs. 3.2%). Biologics were primarily prescribed in the Southeast and South; however, the central-western and northern regions showed greater changes in prescription rates over time. There were increased clusters of high biologic prescriptions across the three evaluated periods.

CONCLUSIONS: The increase in biologic prescriptions over time may be attributed to their enhanced efficacy in inducing and maintaining IBD remission. Biologic prescriptions in Brazil are experiencing temporal and geographical changes, indicating that disparities in drug prescriptions may decrease with universal, equitable healthcare access, despite administrative challenges in obtaining these medications through SUS.

PMID:39950239 | DOI:10.1002/pds.70114

J Am Psychiatr Nurses Assoc. 2025 Feb 14:10783903251315744. doi: 10.1177/10783903251315744. Online ahead of print.

ABSTRACT

INTRODUCTION: Tobacco smoking remains a leading cause of preventable disease and death in the U.S., with a high prevalence among individuals with mental health disorders (MHD). Despite regulatory efforts to increase tobacco use disorder (TUD) treatment in psychiatric inpatient units (an ideal setting), compliance of offering and using these interventions remains suboptimal.

AIMS: This project aims to examine the effectiveness of a nurse-driven protocol, Smoking treatment Protocol for Inpatients via Nurse-driven Interventions & Teaching (SPIN-IT), on improving compliance with evidence-based TUD treatment interventions in an inpatient psychiatric unit.

METHODS: SPIN-IT was developed and implemented in a 20-bed inpatient psychiatric unit. The protocol allowed registered nurses (RNs) to deliver TUD counseling and prescribe nicotine replacement medication based on an algorithm without an independently licensed provider (LIP). Data on compliance with CMS tobacco measures (TOB-2 and TOB-2a) were collected for 12 months before and after SPIN-IT implementation and analyzed for statistical significance.

RESULTS: The project included 835 patients over 2 years. Postintervention TOB-2 compliance increased significantly from 84.7% to 99.3% (p < .001), and TOB-2a compliance rose from 24% to 56% (p < .001). The protocol resulted in more patients being offered and receiving TUD treatment counseling and medications.

CONCLUSION: The SPIN-IT protocol significantly improved TUD treatment compliance in an inpatient psychiatric setting. It supports the effectiveness of nurse-driven protocols in enhancing patient outcomes and adherence to TUD treatment measures. Further research is needed to evaluate the long-term impact on TUD treatment and to explore the perceptions of nursing staff, physicians, and patients related to the protocol.

PMID:39950238 | DOI:10.1177/10783903251315744

Pharmacoepidemiol Drug Saf. 2025 Feb;34(2):e70106. doi: 10.1002/pds.70106.

ABSTRACT

OBJECTIVES: The Observational Medical Outcomes Partnership common data model (OMOP-CDM) is a useful tool for large-scale network analysis but currently lacks a structured approach to pregnancy episodes. We aimed to develop and implement a perinatal expansion for the OMOP-CDM to facilitate perinatal network research.

METHODS: We collaboratively developed a perinatal expansion with input from domain experts and stakeholders to reach consensus. The structure and vocabularies followed the OMOP-CDM ontological framework principles. We tested the expansion using SIDIAP and Norwegian databases. We developed a diagnostics package for quality control assessment and conducted a descriptive analysis on the captured perinatal data mapped to the OMOP-CDM.

RESULTS: The perinatal expansion consists of a pregnancy table and an infant table, each with required and optional variables incorporated into standardized vocabularies. Quality assessment of the perinatal expansion table in SIDIAP and Norwegian databases demonstrated accurate capture of perinatal characteristics. Descriptive analysis measured the number of pregnancies (SIDIAP: 646 530; Norway: 746 671), pregnancy outcomes (e.g., 0.5% stillbirths in SIDIAP and 0.4% in Norway), gestational length (median [IQR] in days, SIDIAP: 273 [56-280]; Norway: 280 [273-286]), number of infants (Norway: 758 806), and birth weight (median [IQR] in grams, Norway: 3520 [3175-3860)], among other relevant variables.

DISCUSSION AND CONCLUSION: We developed and implemented a perinatal expansion that captures important variables for perinatal research and allows interoperability with existing tables in the OMOP-CDM, which is expected to facilitate future network studies. The publicly available diagnostics package enables testing the implementation of the extension table and the quality and completeness of available data on pregnancy and pregnancy-related outcomes in databases mapped to the OMOP CDM.

PMID:39950235 | DOI:10.1002/pds.70106

J Cosmet Dermatol. 2025 Feb;24(2):e70037. doi: 10.1111/jocd.70037.

ABSTRACT

OBJECTIVE: Telogen effluvium, the most common cause of diffuse and non-scarring alopecia in women, is frequently diagnosed in dermatology outpatient clinics and can be caused by various etiological factors such as medications, trauma, emotional, and physiological stress. In patients presenting with complaints of telogen effluvium, we aimed to investigate abnormal levels of serum ferritin, vitamin B12, folic acid, thyroid function tests, and hemoglobin and determine which of these abnormal values might be significantly associated with telogen effluvium.

MATERIAL AND METHODS: In this study, 2851 female patients diagnosed with telogen effluvium who applied to the Dicle University Dermatology outpatient clinic between January 1, 2010 and June 30, 2024 were retrospectively evaluated. The relationship between these laboratory abnormalities and telogen effluvium, as well as their significance in different age groups, was analyzed using the SPSS-27.0 program. Associations were analyzed using Kolmogorov-Smirnov test, dependent t-test, Wilcoxon test, Pearson chi-square (χ²) test, Yates chi-square (χ²) test, Fisher chi-square (χ²) test analysis, Mc-Nemar test, Pearson/spearman correlation analysis, and logistic regression analysis. A p value of < 0.05 was considered statistically significant.

RESULTS: The mean age of 2851 female patients included in our study was 26.33 years, 12.8% (n = 366) were under 18 years of age, 83.5% (n = 2380) were between 18 and 45 years of age, and 3.7% (n = 105) were over 45 years of age. Hemoglobin values were determined in 2496 of 2851 patients and values below the reference range were found in 317 patients (11.1%). Ferritin was found to be low in 1123 (46.5%) of 2413 patients. Vitamin 12 deficiency was detected in 150 (5.8%), folic acid deficiency in 8 (0.6%), and iron deficiency in 685 (29.5%) patients. As can be seen in our study, deficiency of laboratory parameters, especially ferritin and serum iron, is a common finding in female patients presenting with TE.

CONCLUSION: This study showed that biochemical tests, complete blood counts, and hormonal tests are important tools in investigating the etiology and guiding the treatment in patients diagnosed with telogen effluvium, as various etiological factors may be present. Furthermore, it was determined that parameters such as vitamin B12, ferritin, TSH, and T3 hold varying levels of importance during significant phases of women’s physiological development, such as adolescence and post-menopausal periods.

PMID:39950230 | DOI:10.1111/jocd.70037

Emerg Med Australas. 2025 Feb;37(1):e70011. doi: 10.1111/1742-6723.70011.

ABSTRACT

OBJECTIVE: To explore whether utilisation of a Virtual Emergency Department (VVED) differs according to socioeconomic status (SES).

METHODS: A retrospective analysis was undertaken of data from the VVED – a telehealth service that provides care for patients across Victoria, Australia with non-life-threatening emergencies. The study included all individuals who presented to the VVED between July 2022 and June 2023 through the two most common referral pathways (self-referral and ambulance referral). Area-level SES was ascertained by matching residential postcodes to the corresponding Australian Bureau of Statistics (ABS) Index of Relative Socioeconomic Advantage and Disadvantage (IRSAD) decile. IRSAD scores were divided into quintiles (1 = lowest SES, 5 = highest SES) and multivariable logistic regression modelling was used to analyse associations between the SES quintile and referral pathway, presented as odds ratios (ORs) with 95% confidence intervals (CIs).

RESULTS: There were 68 598 participants included in the analyses (mean age: 36.6 years; 58.4% female). Compared to SES quintile 3, higher odds of self-referral to the VVED were observed in the two most advantaged SES groups (Quintile 4; adjusted OR [aOR] = 1.16; 95% CI: 1.06-1.26; P = 0.001) (Quintile 5; aOR = 1.38; 95% CI: 1.25-1.52; P < 0.001). Conversely, lower odds of self-referral were observed in the most disadvantaged SES group (Quintile 1; aOR = 0.82; 95% CI: 0.75-0.90; P < 0.001).

CONCLUSIONS: The present study demonstrated a relatively even utilisation of the VVED service across SES population groups. The use of healthcare provider pathways, such as ambulance paramedics, may increase equitable access to telehealth. Clinical attention should be directed toward specific social groups in the emergency care setting.

PMID:39950229 | DOI:10.1111/1742-6723.70011