Category: Statistics

J Otolaryngol Head Neck Surg. 2026 Jan-Dec;55:19160216251407935. doi: 10.1177/19160216251407935. Epub 2026 Mar 3.

ABSTRACT

BackgroundThere has been a recent increase in the publication of articles evaluating outcomes of balloon dilation of the eustachian tube (BDET) as a treatment for chronic eustachian tube dysfunction (ETD). Our objective was to evaluate the overall efficacy of BDET for treating ETD, with a subgroup analysis of BDET performed under local anesthesia (LA) versus general anesthesia.MethodsPUBMED, EMBASE, and Cochrane databases were searched for English articles from January 2010 to October 2025. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed. Only randomized controlled trials and prospective studies evaluating BDET for ETD were included. All articles evaluating BDET performed under LA were assessed.ResultsOur search identified a total of 23 articles after screening (365 articles). Only studies using homogeneous and validated outcome measures were included. A total of 6 studies met criteria for meta-analysis of preoperative and postoperative outcomes of BDET as assessed by the ETD Questionnaire (ETDQ-7). Other reported parameters include LA protocols and surgical complications. Seven studies used LA protocols. A meta-analysis using the random effects model demonstrated a decrease in mean ETDQ-7 scores by 2.03 up to a year following BDET (309 patients, CI -2.59 to -1.47, P < .001). Descriptive statistics were used to analyze studies where BDET was performed under LA due to outcome heterogeneity. The results demonstrate no significant differences in otologic post-BDET outcomes (tympanometry/ETDQ-7 scores), minimal complications, and high patient-reported willingness to choose LA.ConclusionsBDET is effective for treating chronic ETD. BDET performed under LA with careful patient selection and an established LA protocol is safe and comparable to BDET in the operating room.

PMID:41776716 | DOI:10.1177/19160216251407935

Hum Vaccin Immunother. 2026 Dec;22(1):2633021. doi: 10.1080/21645515.2026.2633021. Epub 2026 Mar 3.

ABSTRACT

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease in all age groups, with substantial burden in older adults. Here, we report the safety and immunogenicity of IVX-121, an investigational virus-like particle vaccine against RSV. This Phase 1/1b trial (EudraCT number: 2020-003633-38) randomized 90 healthy young (18-45 y of age; Phase 1) and 130 older adults (60-75 y of age; Phase 1b) to receive a single intramuscular injection of IVX-121 at low (25 µg), medium (75 µg), or high (250 µg) dose, with/without the adjuvant aluminum hydroxide (Al[OH]₃), or placebo. Outcomes were assessed through Day 180. Older adult participants who had received IVX-121 or placebo could continue into an extension study in which safety was assessed for an additional 6 months before receiving IVX-121 (75 µg, unadjuvanted, open-label) on Day 365; safety and immunogenicity were assessed up to Day 546. Adverse reactions were generally mild, and there were no vaccine-related serious adverse events. All IVX-121 dose levels and formulations boosted preexisting RSV neutralizing antibody (nAb) responses. Although not statistically powered to compare treatment groups, there was no clear dose response and the adjuvant Al(OH)₃ did not appear to improve immunogenicity. For both age groups, IVX-121 induced nAbs against RSV A and B, which remained above baseline levels for at least 6 months. A second dose of IVX-121 in older adults elicited a modest increase in nAbs against RSV A but not RSV B. Overall, IVX-121 had a favorable safety profile and induced immune responses against RSV in young and older adults.

PMID:41776715 | DOI:10.1080/21645515.2026.2633021

Knee Surg Relat Res. 2026 Mar 3;38(1):13. doi: 10.1186/s43019-026-00312-w.

ABSTRACT

AIM: To investigate the variants of lateral hinge fracture and its outcome, as well as to develop a MRI based classification on the fracture line pattern.

METHODS: This retrospective study analyzed 250 knees from 227 patients (169 females, 58 males) who underwent medial opening wedge high tibial osteotomy. Lateral hinge fractures were detected using MRI and classified into four types on the basis of the fracture line pattern: type A (proximal to the tibiofibular joint), type B (into the proximal tibiofibular joint), type C (distal to the tibiofibular joint), and type D (proximal into the joint). Patients were followed up with radiographs and computed tomography (CT) scans to monitor outcome.

RESULTS: Type A fractures had a shorter union time (3.66 months) than type B (5.17 months), type C (6.24 months), and type D (5.75 months). Type B had a delayed union rate of 20%, higher than that of type A (2.46%). Statistical analysis confirmed that type A fractures had significantly better outcomes than types B, C, and D. Type B fractures are by definition Takeuchi type I fractures but exhibit clinical characteristics similar to type II fractures, including longer union times and a higher risk of delayed union.

CONCLUSIONS: Type A fracture has union rates similar to those in non-fracture groups, whereas type B fracture has clinical similarities to Takeuchi type II fractures and therefore should be considered and managed as a subtype of Takeuchi type II fractures.

PMID:41776710 | DOI:10.1186/s43019-026-00312-w

Syst Rev. 2026 Mar 3. doi: 10.1186/s13643-026-03129-6. Online ahead of print.

ABSTRACT

BACKGROUND: In ptotic/macromastic breasts, nipple-sparing mastectomy (NSM) risks ischemic complications. Staging with nipple repositioning (mastopexy or breast reduction) may improve perfusion, but uncertainty remains regarding safety and optimal timing.

METHODS: PRISMA guidelines will be followed. The database search will be conducted using MEDLINE (PubMed), Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and ClinicalTrials.org targeting studies from inception to search date. Meta-analysis will be performed using Review Manager 5.4 software; forest plots will be used for two-arm studies to calculate pooled risk ratios, heterogeneity using I² statistics, and p-value for overall effect.

DISCUSSION: Due to the conflicting studies regarding the optimal timing and safety of nipple-repositioning before NSM, a systematic review and meta-analysis is required to provide more definitive evidence-based recommendations regarding the optimal timing and safety of this staged approach. Limitations may include the predominance of observational studies, heterogeneity in intervals, and inconsistent reporting that may limit the certainty of our conclusions.

SYSTEMATIC REVIEW REGISTRATION: ROSPERO CRD42024513738.

PMID:41776684 | DOI:10.1186/s13643-026-03129-6

Parasit Vectors. 2026 Mar 3. doi: 10.1186/s13071-026-07317-0. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to evaluate and compare the diagnostic performance of the Midi Parasep^® Solvent Free (SF) system and the Ritchie method for detecting helminths and protozoa in clinical stool samples. It also assessed the most suitable concentration technique for different laboratory contexts on the basis of parasitic burden and epidemiological factors.

METHODS: A retrospective comparative study was performed with 100 helminth-positive samples from the Drassanes Vall d’Hebron Microbiology Laboratory (Barcelona, Spain). Samples were previously identified using the Ritchie technique and were reprocessed using the Midi Parasep^® SF system. All samples were examined by expert microscopists and in accordance with World Health Organization protocols and quality standards. Bivariate analysis was performed using the Z-test or Fisher’s exact test, as appropriate, and differences were considered statistically significant at P < 0.05.

RESULTS: The Ritchie method detected 139 parasitic aetiologies, whereas Midi Parasep^® SF identified 85, yielding an overall concordance of 61.15%. While protozoan detection showed 100% concordance between both methods, the correlation for helminths was significantly lower (54.6%; P < 0.001). Midi Parasep^® SF exhibited reduced sensitivity, particularly for larger helminths (e.g., Strongyloides stercoralis, Schistosoma intercalatum) and samples with low parasitic burden. In addition, the Alcorfix^TM fixative agent caused morphological alterations in some helminth eggs and larvae. Midi Parasep^® SF offers operational advantages and hazard reduction; however, the Ritchie method is more sensitive for helminth detection.

CONCLUSIONS: The choice of concentration technique should be guided by the clinical context. Midi Parasep^® SF is efficient for protozoa and suitable for routine use in high-throughput settings. Conversely, the Ritchie method is preferable when helminth infection is highly suspected, particularly in migrant or travel medicine populations. Moreover, other diagnostic techniques, such as serological assays, could contribute to a more accurate diagnosis, thereby guiding the selection of the most appropriate concentration technique.

PMID:41776678 | DOI:10.1186/s13071-026-07317-0

Trop Med Health. 2026 Mar 4. doi: 10.1186/s41182-026-00937-3. Online ahead of print.

ABSTRACT

BACKGROUND: While global estimates of SARS-CoV-2-infected mortality predominantly focus on in-hospital deaths, post-discharge mortality remains an overlooked contributor to the total disease burden, especially in low- and middle-income countries such as Bangladesh. This study aimed to estimate the 30-day post-discharge mortality rate among adult (≥ 18 years) patients with severe acute respiratory infection (SARI) who were SARS-CoV-2-infected and to identify factors associated with these deaths.

METHODS: From March 2020-December 2023, we enrolled hospitalised adult meeting the World Health Organization defiend SARI case defination across nine tertiary care hospitals in Bangladesh. We followed-up with patients or their family members 30-day post-discharge to ascertain survival status. We calculated the proportion of post-discharge deaths among SARS-CoV-2-infected patients and compared the demographic and clinical characteristics of decedents versus survivors. Data were summarised using descriptive statistics, t-test, Fisher’s exact test, and Chi-square tests. We used multivariable Cox’s regression models to calculate the adjusted hazard ratio (aHR) to identify factors associated with SARS-CoV-2-infected adult patient’s deaths during 30-day post-discharge period.

RESULTS: Among 7,816 patients enrolled [mean age 47 years (± 47.7), 62% male], 1,280 (16.4%) were SARS-CoV-2-infected. Of them, 126 (9.8%) died during their hospital stay. Among the 1154 patients discharged alive, 1,108 (96%) were successfully followed up, and 111 (10%) died within 30 days post-discharge. The most frequently reported symptoms among post-discharge decedents included difficulty breathing (105; 94.6%), body ache (55; 49.6%), headache (44; 39.6%), with over half (59; 53.1%) having at least one pre-existing condition. Post-discharge mortality was approximately fourfold higher among prematurely discharged patients (aHR: 4.13; 95% CI 1.52-11.23), nearly fourfold higher in those with difficulty breathing (aHR: 3.69; 95% CI 1.62-8.43), and more than threefold higher among patients with kidney disease (aHR: 3.35; 95% CI 1.34-8.38) compared with their counterparts.

CONCLUSIONS: Nearly one in five adult patients with SARS-CoV-2-infected SARI in Bangladesh died either during hospitalisation or within 30-day of post-discharge, with almost half of these deaths occurring after discharge. Study findings underscore the urgent need to strengthen discharge planning, such as developing and implementing standardised discharge guidelines, prioritising high-risk patients such as premature discharge for targeted post-discharge follow-up, and implementing structured post-discharge care interventions to reduce preventable mortality in resource-limited settings.

PMID:41776628 | DOI:10.1186/s41182-026-00937-3

Reprod Biol Endocrinol. 2026 Mar 3. doi: 10.1186/s12958-026-01539-8. Online ahead of print.

NO ABSTRACT

PMID:41776626 | DOI:10.1186/s12958-026-01539-8

Eur J Med Res. 2026 Mar 4. doi: 10.1186/s40001-026-04021-8. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical observations indicate a correlation between frailty and lower urinary tract symptoms (LUTS) in men. We further investigated this relationship via data from two extensive population-based studies.

METHODS: We performed a cross-sectional study via the National Health and Nutrition Examination Survey (NHANES) and the China Health and Retirement Longitudinal Study (CHARLS). Participants lacking exposure variables, outcome variables, and important covariates were not included. The frailty index (FI) was used to evaluate frailty. In CHARLS, LUTS is defined as a previous diagnosis of benign prostatic hyperplasia. In NHANES, the presence of LUTS was defined as 2 or more symptoms, including hesitancy, incomplete emptying and/or nocturia. After taking into account the covariates (demography, chronic diseases, and unhealthy lifestyles), multivariable logistic regression was employed to examine the association between frailty and LUTS. Furthermore, subgroup analysis was conducted to investigate the influence of covariables on the association between frailty and LUTS. The mediating role of depression was ultimately examined.

RESULTS: Finally, our study included 1735 participants from NHANES and 5008 participants from CHARLS. The NHANES findings indicated a positive connection between frailty and LUTS [OR 1.97, 95% CI (1.53, 2.55)] after controlling for all the variables. The link persisted when FI was set as a categorical variable [Q3, 1.78 (1.05, 3.02); Q4, 2.95 (1.76, 4.93)]. The CHARLS findings indicated a positive connection between frailty and LUTS [1.64 (1.21, 2.23)] after controlling for all variables. The connection persisted when FI was designated as a categorical variable [Q2, 1.73 (1.31, 2.28); Q3, 2.15 (1.64, 2.83); Q4, 3.11 (2.36, 4.09)]. Depression partly mediated the relationship between frailty and LUTS (18.20% in NHANES; 19.63% in CHARLS).

CONCLUSIONS: A high FI was correlated with a greater risk of LUTS in both the US and Chinese men. The relationship between frailty and LUTS was partly explained by depression.

PMID:41776600 | DOI:10.1186/s40001-026-04021-8

BMC Med. 2026 Mar 4. doi: 10.1186/s12916-026-04754-7. Online ahead of print.

ABSTRACT

BACKGROUND: Cardiovascular-kidney-metabolic (CKM) disease and chronic obstructive pulmonary disease (COPD) are associated with major adverse cardiovascular events (MACE). Whether COPD further increases MACE risk within CKM populations, and whether this potential risk is modifiable through inhaled corticosteroids (ICS), is unknown. Within CKM populations, we investigated the relationship between (1) COPD and subsequent MACE, and (2) amongst concurrent CKM-COPD populations, we investigated the relationship between ICS and subsequent MACE.

METHODS: We used Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics and Office of National Statistics data, between January 1st, 2010, and March 29th, 2021. We created five discrete cohorts: chronic kidney disease (CKD), type-II diabetes mellitus (T2DM), obesity, MACE history, and older adults (aged ≥ 65 years old [“Age65 + “]). CKD, T2DM, obesity, and Age65 + cohorts were MACE-naïve at the time of inclusion. Aim (1) exposures were (a) COPD, (b) incident COPD, and (c) being at risk of COPD without diagnosis (defined as age ≥ 40 years old, smoking history, no evidence of asthma, and frequent respiratory infections requiring antibiotics). Aim (2) exposure was ICS prescription (control group: long-acting bronchodilators). The outcome was MACE (acute coronary syndrome, arrhythmia, heart failure, ischaemic stroke, or cardiovascular-specific mortality). We implemented Cox proportional hazards models.

RESULTS: COPD was associated with MACE amongst all cohorts, but was comparatively weak in the MACE history cohort (cohort total; adjusted hazard ratio [95% confidence interval]): CKD (N = 573,626; 1.29 [1.26, 1.32]), T2DM (N = 649,506; 1.30 [1.26, 1.35], obesity (N = 225,273; 1.41 [1.34, 1.48]), MACE history (N = 507,889; 1.04 [1.02, 1.06]), and Age65 + (N = 592,123, 1.59 [1.52, 1.66]). Incident COPD was associated with subsequent MACE in CKD only (1.28 [1.13, 1.45]). Being at risk of COPD was associated with subsequent MACE in CKD (1.18 [1.07, 1.30]), MACE history (1.16 [1.08, 1.25]), and Age65 + (1.28 [1.13, 1.46]). ICS prescription was not associated with subsequent MACE in any concurrent CKM-COPD cohort.

CONCLUSIONS: COPD was an independent risk factor for MACE in CKM populations. ICS did not attenuate MACE amongst CKM-COPD groups. Incident COPD was associated with MACE in CKD, and being at risk of COPD was associated with MACE in CKD, MACE history, and Age65 + cohorts.

PMID:41776594 | DOI:10.1186/s12916-026-04754-7

Biol Sex Differ. 2026 Mar 3. doi: 10.1186/s13293-026-00865-1. Online ahead of print.

ABSTRACT

BACKGROUND: Parkinson’s disease (PD) is a neurodegenerative disorder with established sex differences in incidence and progression. Epidemiological evidence suggests nicotine may confer protection against PD, but its mechanisms, particularly regarding sex-specific effects, remain unclear. This study investigated the neuroprotective mechanisms of nicotine in a rotenone-induced PD rat model, with a specific focus on evaluating sex-dependent modulation across behavioral, pathological, and gut-related outcomes.

METHODS: Male and female Sprague-Dawley rats were administered rotenone (2 mg/kg/day, s.c.) for four weeks to induce PD. Nicotine (0.5 mg/kg/day, s.c.) was administered 30 min after rotenone. Motor function was assessed using rotarod and CatWalk XT gait analysis. Neuropathology in the substantia nigra was evaluated via immunofluorescence for α-synuclein and tyrosine hydroxylase (TH). Gut pathology was analyzed through colon histopathology (H&E staining) and ELISA for IL-6 and α-synuclein. Gut microbiota composition was assessed by 16 S rDNA sequencing, and serum metabolomics was performed using UPLC-MS/MS. Data were analyzed by two-way ANOVA with Tukey’s post-hoc test.

RESULTS: Nicotine significantly attenuated rotenone-induced motor impairments: males showed a superior response in balance-related parameters, while females exhibited enhanced efficacy in dynamic gait metrics. Pathologically, nicotine reduced nigral α-synuclein accumulation and TH depletion in both sexes, with males showing greater α-synuclein accumulation following rotenone exposure. Crucially, nicotine exclusively ameliorated colon histopathology, reduced plasma α-synuclein, and suppressed colon IL-6 in females, while attenuating intestinal α-synuclein accumulation in both sexes. Microbiota analysis revealed sex-divergent taxonomic shifts with nicotine treatment. Metabolomics showed significantly more extensive metabolic reprogramming in females, particularly affecting indole derivatives. Pearson correlations revealed significant sex-specific associations between altered serum indole derivatives and gut microbiota genera.

CONCLUSIONS: Nicotine exerts neuroprotection in PD through sex-dependent modulation of multiple pathological pathways, primarily involving the gut-microbiota-metabolite axis. Females benefit from enhanced gastrointestinal protection and metabolic reprogramming, while males show preferential motor balance restoration. These findings underscore the critical importance of sex-stratified therapeutic strategies for PD.

PMID:41776571 | DOI:10.1186/s13293-026-00865-1