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Nevin Manimala Statistics

The Effect of Two-Piece Abutment Concept and Abutment Reconnection/Disconnection on Marginal Bone Level Changes: A Split-Mouth Randomized, Parallel-Designed, 36-Month Follow-Up, Preliminary Clinical Study

Int J Oral Maxillofac Implants. 2025 Sep 4;0(0):1-28. doi: 10.11607/jomi.11454. Online ahead of print.

ABSTRACT

PURPOSE: The objective of this study was to conduct a comparative evaluation of the clinical and radiographic findings of definitive two-piece abutments placed at secondary surgery following submerged healing and definitive abutments used in standard prosthetic treatments.

MATERIALS AND METHODS: The study was designed as a prospective, split-mouth, randomised, parallel-design, blinded clinical trial. The study comprised two groups: a test group and a control group. The test group received a two-piece abutment, while the control group received a standardized healing abutment. The study analyzed a total of 10 patients and 20 implants. Clinical and radiographic measurements were obtained at baseline (T0), 6 months (T1), 12 months (T2) and 36 months follow-up (T3). Radiographic measurements were calculated on standardized periapical radiographs, with the aim of determining marginal bone level changes (ΔMBL) at different time points, emergence angles, and emergence profiles in mesially and distally.

RESULTS: A significant difference was found between the groups in mesial, distal, and mean ΔMBL at T0-T1 and distal and mean ΔMBL at T0-T3 values. (p<0.05) Emergence angle values were found to be below 30 degrees both mesially and distally in both groups. (p>0.05) A statistically significant correlation was found between healing/definitive abutment disconnection/reconnection and distal ΔMBL T0-T3. (p<0.05) Conclusion: Within the limitations of the study, although the sample size was limited, with the study design and minimizing confounding factors, it was concluded that two-piece definitive abutment application may have significant effects in terms of reducing ΔMBL changes in both the short and long term. However, further studies with a larger sample size are needed. The study was prospectively registered on the international Clinicaltrials.com registry (NCT05592821).

PMID:40907027 | DOI:10.11607/jomi.11454

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Nevin Manimala Statistics

Periodic Assessment of Trajectories of Housing, Homelessness, and Health Study (PATHS): Protocol for a Prospective Cohort Study of People Experiencing Homelessness

JMIR Res Protoc. 2025 Sep 4;14:e74266. doi: 10.2196/74266.

ABSTRACT

BACKGROUND: The past decade has seen a substantial increase in the number of people experiencing unsheltered homelessness. The unsheltered population faces heightened health and social risks, yet research on their experiences remains limited.

OBJECTIVE: This paper presents the protocol for the Periodic Assessment of Trajectories of Housing, Homelessness, and Health Study (PATHS), a longitudinal study that leverages mobile phone technology and web-based surveys to track the housing and health trajectories of people experiencing unsheltered homelessness in Los Angeles County.

METHODS: Participants were recruited from the Los Angeles County Homeless Count Demographic Survey, an annual representative survey of the county’s unsheltered population. Eligibility criteria included being aged ≥18 years, having stayed in an unsheltered location or homeless shelter for at least 1 night in the past month, and residing in Los Angeles County. The study uses a web-based survey platform accessible via mobile phones and provides electronic gift card incentives for participation. Data on housing, health, and social outcomes are collected monthly using trauma-informed, equity-sensitive surveys, designed for diverse literacy levels with a user-friendly interface that includes buffers for sensitive topics.

RESULTS: Since the study launched in December 2021, a total of 2058 individuals have been screened and found eligible. In total, 57.43% (n=1182) of participants completed the baseline survey, of whom 75.47% (n=892) completed at least 1 monthly survey. By December 2024, participants had contributed 7585 monthly surveys (average of 8.5, SD 8.36 per respondent and median of 6, IQR 2-11). Compared to the unsheltered population of Los Angeles County, the PATHS sample overrepresents younger adults aged <40 years (641/1182, 54.23% vs 38.64%) and female participants (507/1182, 42.89% vs 27.74%). Furthermore, the PATHS cohort reports a high burden of health risks relative to the housed population, with 47.3% (422/892) reporting symptoms of anxiety (vs 19.1%), 45.1% (402/892) reporting symptoms of depression (vs 16.4%), 35% (312/892) reporting a disability (vs 12.9%), and 69.4% (619/892) experiencing food insecurity (vs 15.7%).

CONCLUSIONS: PATHS offers an innovative platform for real-time monitoring of the housing, health, and service needs of people experiencing unsheltered homelessness in Los Angeles County. By leveraging continuous, in-depth data collection via mobile surveys, PATHS provides valuable insights into the evolving challenges faced by this population. Addressing critical gaps in longitudinal research, PATHS has the potential to drive more informed policy decisions and interventions that improve outcomes for this population considered vulnerable.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/74266.

PMID:40907020 | DOI:10.2196/74266

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Nevin Manimala Statistics

Informing Facility Selection Through a Web-Based User Ratings System: Protocol for a Randomized Controlled Trial Among Mothers in Urban Lao People’s Democratic Republic

JMIR Res Protoc. 2025 Sep 4;14:e66085. doi: 10.2196/66085.

ABSTRACT

BACKGROUND: Despite the increasing options for public and private health care providers in the Lao People’s Democratic Republic (Lao PDR), choosing a high-quality provider or facility is difficult because timely and reliable information about providers is not readily available. Additionally, only 28% described their most recent visit to a health care provider as high quality, suggesting that while options for care are expanding, people may need support in finding providers that meet their quality needs. To inform efforts to improve access to high-quality care, evidence is needed on mechanisms that empower people to identify and use such care. The rapid adoption of mobile phones in Lao PDR, particularly in urban areas, offers opportunities to enhance access to timely, reliable information about health care facilities.

OBJECTIVE: This study aims to conduct an unblinded randomized controlled experiment using mobile phones to study whether routinely collected information on quality of care can improve access to high-quality care and patient satisfaction.

METHODS: Mothers with at least one child under 2 years of age who are already enrolled in the Vientiane Multigenerational Birth Cohort (VITERBI) will be invited to participate during in-person visits by the research staff. Participants will be randomly assigned in equal numbers to the control and intervention groups. The intervention group will receive a URL with facility ratings for pediatric health care services every 2 weeks via WhatsApp; the control group will not receive any messages. WhatsApp will also be used to administer biweekly surveys to both groups to assess the quality of care received in the past 2 weeks. The web page shared with the intervention group will display results from these surveys and from the pilot study. Research staff will conduct baseline and endline surveys with all participants during in-person visits, 3 months apart.

RESULTS: The trial is currently underway and scheduled for completion in 2025.

CONCLUSIONS: This study will use a demand-side intervention to increase demand for high-quality child health care among mothers in Vientiane Capital. We will assess whether information on the quality of health care facilities-generated by study participants during the study period-influences mothers to change their preferred providers for nonurgent conditions.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06304831; https://www.clinicaltrials.gov/study/NCT06304831.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66085.

PMID:40907019 | DOI:10.2196/66085

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Patient Demographics and Risk Factors for Surgical Site Infections After Open Reduction and Internal Fixation for Bimalleolar Ankle Fractures

J Am Acad Orthop Surg. 2025 Aug 28. doi: 10.5435/JAAOS-D-24-01181. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to identify the incidence and risk factors associated with surgical site infection (SSI) after open reduction and internal fixation of bimalleolar ankle fractures. Bimalleolar ankle fractures are one of the most common subtypes of ankle fractures, accounting for 15% to 20% of all ankle fractures. Recent studies have shown that 4.37% of patients undergoing ORIF of ankle fractures develop an SSI postoperatively. The literature detailing the risk factors for the development of SSI after open reduction and internal fixation (ORIF) of bimalleolar ankle fractures is sparse. Therefore, the purpose of this study was to determine the risk factors that predispose patients to SSI after the index procedure.

METHODS: Patients who underwent bimalleolar ankle fracture repair between January 1, 2010, and December 31, 2021, were identified using the PearlDiver Mariner Database. Demographics and comorbidities between SSI and non-SSI cohorts were compared through chi-square analysis. Multivariate logistic regression was used to analyze risk factors for SSIs. A P value less than 0.001 was determined to be statistically significant.

RESULTS: The incidence of SSI after ORIF of bimalleolar ankle fractures was 3.1%. Age, sex, and a higher total Elixhauser Comorbidity Index were associated with an increased incidence of SSI (P < 0.0001). Risk factors for the development of SSI included male sex (OR = 1.17; P < 0.0001), chronic kidney disease (odds ratio [OR] = 1.233; P < 0.001), diabetes (OR = 1.27; P < 0.0001), drug abuse (OR = 1.22; P < 0.0001), fluid and electrolyte disorders (OR = 1.42; P < 0.0001), hypertension (OR = 1.29; P < 0.0001), peripheral vascular disease (OR = 1.62; P < 0.0001), tobacco use (OR = 1.25; P < 0.0001), and weight loss (OR = 1.25; P < 0.0001). Peripheral vascular disease was the most highly correlated risk factor for the development of SSIs in this study.

CONCLUSIONS: These findings underscore the importance of preoperative risk stratification and optimization to minimize SSIs in this population. This is the first study to delineate the risk factors for the development of SSI in patients undergoing ORIF for bimalleolar ankle fractures. Physicians can use these results to counsel patients before undergoing the index procedure to minimize postoperative infections.

LEVELS OF EVIDENCE: IV.

PMID:40907002 | DOI:10.5435/JAAOS-D-24-01181

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Recalls of Arthroscopic Equipment After Food and Drug Administration 510(k) Approval: A Twenty-Year Analysis of Causes, Trends, and Time to Recall (2004 to 2024)

J Am Acad Orthop Surg. 2025 Aug 28. doi: 10.5435/JAAOS-D-25-00371. Online ahead of print.

ABSTRACT

BACKGROUND: Current reliance on the expedited 510(k) approval pathway has driven rapid commercial availability of novel arthroscopic devices. Despite the low complication rates of arthroscopic procedures, products from this pathway are suspected to increase the rate of recalls and device malfunctions.

PURPOSE: This study aimed to characterize arthroscopic device recalls, analyze trends in recall incidence, and identify predictors of time to recall.

METHODS: A 20-year, retrospective, cross-sectional study was conducted using the Food and Drug Administration (FDA) Recalls database. Recalled devices approved under the FDA 510(k) pathway were identified and categorized by type, manufacturer, recall class, and cause. Statistical analyses included Poisson regression for trends and Cox proportional hazards modeling for predictors of time to recall.

RESULTS: A total of 124 recalls were initiated during the study period (average 6.2 recalls/year), with packaging and process control issues accounting for 50.7% of recalls. Recall incidence remained stable over time, although nearly half occurred in 2008, 2010, 2012, and 2019. Mean recall time was 491 days (95% confidence interval [CI], 444 to 539). Devices recalled due to material/implant contamination had markedly shorter times (HR: 3.73 [95% CI, 1.78 to 7.82]), whereas process control issues prolonged recall times (HR: 0.56 [95% CI, 0.31 to 1.00]). Manufacturer was another predictor of time to recall, with one manufacturer exhibiting substantially extended recall times (HR: 0.45 [95% CI, 0.22 to 0.92]).

CONCLUSION: Arthroscopic device recalls are largely caused by packaging and process control issues, emphasizing the need for stricter quality assurance during manufacturing. Although recall incidence remained stable over the past two decades, variability in recall times highlights opportunities for improved manufacturer accountability and FDA oversight. Increasing procurement scrutiny, enhancing FDA audit practices, and integrating recall data with clinical outcomes can minimize disruptions in arthroscopic surgery.

LEVEL OF EVIDENCE: Level III Therapeutic Study.

PMID:40906998 | DOI:10.5435/JAAOS-D-25-00371

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Silicosis Surveillance in California, 2019-2024: Tracking an Epidemic

Am J Public Health. 2025 Sep 4:e1-e9. doi: 10.2105/AJPH.2025.308225. Online ahead of print.

ABSTRACT

Objectives. To characterize the nature, burden, and trends of silicosis among California workers, including workers with engineered stone exposures. Methods. We conducted multisource public health surveillance and generated descriptive statistics, compared engineered stone cases to cases with other silica exposures, and examined the utility of various data sources for silicosis surveillance. Results. We received 1817 reports of possible silicosis for 648 individuals from 2019 to 2024 and confirmed 296 (46%) cases, including 243 (82%) associated with engineered stone exposures. Engineered stone cases were more likely to be younger, men, Latino, and from Los Angeles County than were non-engineered stone cases. Of engineered stone cases, at least 15 (6%) were known to have died, and 60 (25%) were referred for lung transplant, including 30 (12%) who received transplants. There was limited overlap between reporting mechanisms. Conclusions. Multisource surveillance was effective for identifying a large number of individuals with silicosis, including people exposed to engineered stone. Outcomes were severe, and many patients had advanced disease. Results illustrate that worker screening and silica exposure mitigation are essential to prevent morbidity and mortality in the engineered stone countertop fabrication industry. (Am J Public Health. Published online ahead of print September 4, 2025:e1-e9. https://doi.org/10.2105/AJPH.2025.308225).

PMID:40906995 | DOI:10.2105/AJPH.2025.308225

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Adolescent Mental Health Assessment in Family Medicine and Specialty Settings in Appalachian Upstate South Carolina to Include Sexting Frequency and Depression Indices

Issues Ment Health Nurs. 2025 Sep 4:1-11. doi: 10.1080/01612840.2025.2522229. Online ahead of print.

ABSTRACT

Sexting is associated with adolescent depression. This study aimed to expand provider assessment in Family Medicine and specialty settings in Appalachian Upstate South Carolina (AUSC) to include sexting and depression screening. AUSC depression rates are among the highest in the nation, highlighting disparities in the region. This nurse-led mixed-method, exploratory descriptive study included adolescents 11 to 18 years old and providers from an AUSC healthcare system, including nurse researchers, nurse practitioners, and physicians. Following education on sexting, depression, and screening, providers in Family Medicine and specialty settings administered the Intimate Images Diffusion Scale and PHQ-2 to adolescents at episodic visits. Concurrently, providers completed a survey on the barriers and facilitators to talking with parents/guardians (P/G) and adolescents about sexting with each participant, including provider comments. Providers also gave P/G a sexting education notebook to take with them. Surveys were analysed using SPSSv24 statistical software, and comments were analysed using thematic analysis. Over 50% screened positive for sexting, and over 40% of those who sexted screened positive for depression. Providers reported few barriers, with P/G (71.9%) and adolescents (81.3%) talking about sexting. The themes were P/G openness to conversations about sexting, P/G awareness of sexting risks, P/G concerns about sexting, adolescent openness to conversations about sexting, and provider facilitators and barriers to discussing sexting. Provider education and screening is a crucial first step in identifying adolescent sexting and depression. Screening in Family Medicine and specialty settings in rural, underserved areas may lead to earlier diagnosis and treatment and improved patient outcomes.

PMID:40906983 | DOI:10.1080/01612840.2025.2522229

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Association of Distinct Initial β-Amyloid Levels With Tau Pathology Expansion Beyond the Entorhinal Cortex

Neurology. 2025 Sep 23;105(6):e214041. doi: 10.1212/WNL.0000000000214041. Epub 2025 Sep 4.

ABSTRACT

BACKGROUND AND OBJECTIVES: β-Amyloid (Aβ) likely triggers the spread of pathologic tau from the entorhinal cortex (EC) to the neocortex, but whether distinct Aβ levels exert differential influences on tau propagation beyond the EC remains unclear. We aimed to investigate the modifying effect of Aβ on the association of initial tau deposition with successive tau accumulation.

METHODS: A retrospective analysis was performed using data from 2 longitudinal observational cohort studies, the Alzheimer’s Disease Neuroimaging Initiative (ADNI) and the Harvard Aging Brain Study (HABS), both conducted in the United States. All participants underwent a baseline study visit that included amyloid PET scans, [18F]-flortaucipir PET scans, and at least 1 follow-up tau PET scan (amyloid positivity was not required). Linear mixed-effects models were fitted to examine the modifying effect of Aβ on the relationship between baseline EC tau levels and tau accumulation over time. The outcome variables included changes in tau PET in 6 regions of interest (ROIs): the entorhinal, inferior temporal (IT), inferior parietal (IP), meta-temporal (meta-ROI), Braak III-IV, and Braak V-VI regions.

RESULTS: This study included 434 older adults from ADNI (262 [60%] cognitively unimpaired [CU] and 172 [40%] cognitively impaired participants; mean age, 73 ± 7 years; 51% female; mean follow-up duration, 3.69 ± 1.98 years) and 200 CU participants from HABS (mean age, 72 ± 9 years; 61% female; mean follow-up duration, 4.33 ± 1.75 years). In ADNI, the 3-way interaction of baseline EC tau × centiloid (CL) × time was significant across all 6 ROIs (e.g., IT region: estimate = 0.00285, 95% CIs 0.00161-0.00408; p < 0.00001), as was baseline EC tau × CL2 × time (e.g., IT region: estimate = -0.00002, 95% CIs -0.00003 to -0.00001; p = 0.00001). The negative quadratic term suggests that the potentiating association between CL and tau spread diminishes beyond a critical threshold. A similar pattern of findings was replicated in HABS.

DISCUSSION: Distinct initial Aβ levels seem to interact with EC tau deposition to affect successive tau accumulation in the rest of the brain. Interpretation should be approached with caution because causality cannot be inferred from this observational study.

PMID:40906972 | DOI:10.1212/WNL.0000000000214041

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Bricker Urinary Diversion after Radical Cystectomy: A Comparative Analysis of Laparoscopic vs. Robotic Approach in Terms of Quality of Life, Perioperative Outcomes and Postoperative Complications

Chirurgia (Bucur). 2025 Aug;120(4):446-458. doi: 10.21614/chirurgia.3156.

ABSTRACT

Introduction: Radical cystectomy with ileal conduit urinary diversion (Bricker technique) remains the standard treatment for localized muscle-invasive bladder cancer (MIBC), as well as for high-risk non-muscle-invasive bladder cancer (NMIBC). Amid the transition toward minimally invasive techniques, comparing laparoscopic radical cystectomy (LRC) with robot-assisted radical cystectomy (RARC) becomes essential, particularly regarding perioperative morbidity and postoperative health-related quality of life. However, real-world data from Eastern Europe remain limited. Objective: To compare peri- and postoperative clinical outcomes and quality of life in patients undergoing radical cystectomy with Bricker urinary diversion via laparoscopic versus robotic approach. Materials and Methods: This is a retrospective, observational study conducted between March 2023 and March 2025 in two academic centers in Cluj-Napoca, Romania. A total of 37 patients diagnosed with MIBC were included and allocated into two groups based on the surgical approach: laparoscopic (n=22) and robotic (n=15). Clinical, biological, and surgical parameters were collected pre- and postoperatively. Quality of life was assessed at 3 months using the EQ-5D-5L and EQ-VAS instruments. Statistical analyses included t-tests, Mann-Whitney U tests, linear regression models, and correlation coefficients, with a significance threshold of p 0.05. Results: The robotic group demonstrated significantly better postoperative renal function (eGFR: 84.2 +- 5.88 vs. 66.55 +- 5.59 ml/min/1.73m²; p=0.041) and a shorter median hospital stay (7 days, IQR 6â?”8 vs. 9 days, IQR 7â?”13; p=0.045), despite a longer operative time (463 +- 25.4 vs. 415 +- 21.52 minutes). Severe postoperative complications were significantly more frequent in the laparoscopic group (54.5% vs. 6.7%; p=0.004). Preexisting urinary tract infections, more common in the LRC group (45.5% vs. 20%), were independently associated with decreased postoperative renal function (ò = -0.39, p=0.005). The mean EQ-VAS score was higher in the robotic group (84.93 +- 2.64 vs. 76.81 +- 4.42; p 0.01), despite a lower EQ-5D-5L utility index (0.52 +- 0.12 vs. 0.72 +- 0.05; p=0.02), indicating an overall favorable health perception despite objectively reduced functional outcomes. Postoperative complications were significantly correlated with decreased EQ-VAS scores (71.39 +- 20.49 vs. 88.37 +- 71.13; p=0.004). Conclusions: In the real-world clinical setting of Eastern Europe, the robotic approach to radical cystectomy with Bricker urinary diversion was associated with better preserved renal function, shorter hospitalization and a lower incidence of severe complications. Preoperative urinary tract infections negatively impacted renal function independently of baseline eGFR. Although RARC patients showed more pronounced functional impairments as measured by EQ-5D-5L, their overall health perception (EQ-VAS) was significantly better, suggesting the influence of technological expectations and postoperative satisfaction. These results support the implementation of robotic surgery in advanced urological centers and highlight the need for prospective, randomized trials with extended follow-up focusing on functional outcomes and quality of life.

PMID:40906957 | DOI:10.21614/chirurgia.3156

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Evaluation of Tensile Strength of Hand Sewn Anastomoses after Gastric Resections – An Experimental Ex Vivo Study

Chirurgia (Bucur). 2025 Aug;120(4):432-437. doi: 10.21614/chirurgia.3138.

ABSTRACT

Introduction: This study aimed to evaluate the resistance of anastomoses to mechanical traction in an ex vivo biomechanical experiment, to determine the most resistant manual suture for restoring digestive tract continuity after various types of gastric resection for cancer. Materials and methods: The tensile strength of different types of anastomoses was compared ex vivo using porcine esophagus, stomach, and small intestine. The test setup included a tensile testing device, which applied a controlled force on the anastomoses until they broke, which was recorded for each type of anastomosis and was expressed in N. Data processing and statistical analysis were performed in the GraphPad Prism program, using a paired T-test and ANOVA test. We considered the p-value 0.05 to be statistically significant. Results: Double-layer gastrojejunal (Roux-en-Y) and end-to-end esophagojejunal anastomosis presented the highest tensile strength. Double-layer anastomoses showed significantly higher tensile strength compared to monoplane ones. The results suggest that the double-layer suture technique offers better mechanical stability, which may reduce the risk of postoperative complications. Conclusions: Biplane anastomoses after gastric resections may reduce postoperative complications and improve patient outcomes.

PMID:40906955 | DOI:10.21614/chirurgia.3138