Category: Statistics

Confl Health. 2026 Apr 25. doi: 10.1186/s13031-026-00792-3. Online ahead of print.

ABSTRACT

BACKGROUND: Contraception is a vital component of reproductive health, yet refugee women often face multiple barriers to accessing family planning (FP) services. This study aimed to explore contraception experiences, practices, and adherence among Syrian refugee women in Lebanon and to identify key sociodemographic predictors influencing contraceptive use.

METHODS: A descriptive, cross-sectional study was conducted between November 2023 and March 2024 among 790 married Syrian refugee women aged 18-50 across four Lebanese governorates. Structured face-to-face interviews were conducted using a validated questionnaire. Descriptive statistics and logistic regression were used to analyze the data.

RESULTS: Nearly 45% had experienced an unplanned pregnancy, with 27.4% resulting in spontaneous miscarriage and 11.3% ending in medical or surgical abortion. About 67.1% were using contraception, with withdrawal (33.2%), intrauterine devices (30.4%), and oral contraceptive pills (OCPs) (19.8%) being the most frequently used method. Among OCP users, 40% were unaware of the medication name, though adherence was generally high (mean score = 21.95 ± 3.68 on a 25-point scale). Logistic regression showed that higher parity (adjusted odds ratio [AOR] = 41.03), residing in Lebanon more than ten years (AOR = 1.57), and employment (AOR = 1.49) were significant predictors of contraceptive use (p < 0.001). Primary barriers to non-use included the desire for more children (31.9%) and spousal opposition (20.4%). More than half of the participants (52.8%) reported at least one chronic condition, with migraine with aura, hypertension, and cardiovascular disease being most common.

CONCLUSION: The high prevalence of unplanned pregnancy (44.5%) and reliance on traditional methods (33.2%) highlight critical gaps in reproductive healthcare. For women with an unmet need for contraception, cultural, informational, and systemic barriers hinder access to modern methods. Improving education, engaging men in FP initiatives, strengthening healthcare infrastructure, and enhancing access to affordable contraceptive methods are essential for advancing reproductive autonomy and health in this vulnerable population.

PMID:42032755 | DOI:10.1186/s13031-026-00792-3

J Orthop Surg Res. 2026 Apr 24. doi: 10.1186/s13018-026-06863-8. Online ahead of print.

ABSTRACT

AIMS: To compare the clinical outcomes and complication profiles of open reduction and internal fixation with plate (ORIF-P) versus reduction and internal fixation with threaded Kirschner wire (ORIF-TKW) for midshaft clavicular fractures (MCFs).

METHODS: A retrospective analysis was conducted on patients with MCFs who underwent either ORIF-P or ORIF-TKW between January 2012 and October 2023. Based on the surgical technique, patients were divided into ORIF-P and ORIF-TKW groups. The two groups were compared in terms of intraoperative blood loss, operative duration, radiographic union duration, shoulder function (Constant-Murley score and Disabilities of the Arm, Shoulder, and Hand [DASH] score), complication rates, and implant removal characteristics.

RESULTS: Of 128 eligible patients, 85 received ORIF-P and 43 received ORIF-TKW. The ORIF-TKW group demonstrated more favorable peri‑operative metrics: shorter operative time (51.5 ± 6.4 vs. 63.6 ± 5.7 min, p < 0.001), less blood loss (38.7 ± 5.6 vs. 56.2 ± 10.1 ml, p < 0.001), and smaller incision length (3.9 ± 0.7 vs. 8.8 ± 0.9 cm, p < 0.001). Radiographic union occurred earlier in ORIF-TKW (median 5.0 vs. 6.0 months, p < 0.001). All 43 patients in the ORIF‑TKW group underwent planned implant removal, with minimal operative time and blood loss, whereas in the ORIF‑P group, only 50 patients (58.8%) underwent removal, exclusively for symptomatic reasons or patient request, with significantly more invasive removal procedures (p < 0.001). Functional outcomes at 6 months were equivalent. Complication rates did not differ significantly between groups. Two refractures in the ORIF P cohort were successfully revised using ORIF TKW.

CONCLUSION: In this single-center retrospective study, ORIF-TKW was associated with superior peri-operative outcomes, earlier radiographic union, and a less invasive planned removal procedure compared with ORIF-P, while functional recovery was similar. A post-hoc analysis demonstrated statistical comparability in fracture complexity within the 2B subgroup, partially mitigating concerns regarding selection bias. However, these findings remain hypothesis-generating and subject to residual confounding; prospective randomized trials with stratification based on fracture morphology are required before any change in routine practice can be recommended. The limited revision experience (2 cases) is insufficient to endorse threaded K-wire fixation as a routine salvage strategy.

PMID:42032746 | DOI:10.1186/s13018-026-06863-8

Trials. 2026 Apr 24. doi: 10.1186/s13063-026-09731-2. Online ahead of print.

ABSTRACT

BACKGROUND: Adenomyosis, an estrogen-dependent condition characterized by endometrial invasion into the myometrium, is associated with reduced live birth rates and increased miscarriage risk in women undergoing assisted reproductive technologies (ART). Gonadotropin-releasing hormone agonists (GnRH-a) are commonly used for pretreatment before frozen-thawed embryo transfer (FET) in adenomyosis patients, but optimal duration remains unclear. Letrozole, an aromatase inhibitor, may enhance GnRH-a efficacy by mitigating its flare-up effect and reducing peripheral estrogen production, yet high-level evidence on their combined effect is lacking. This study aims to compare the live birth rate and other pregnancy outcomes between one and two doses of GnRH-a pretreatment with or without letrozole supplementation in women with adenomyosis undergoing FET.

METHODS: This is a 2 × 2 factorial, multi-center, open-label, randomized controlled trial (RCT) conducted at three reproductive medical centers in China, with a planned enrollment of 432 women aged 20-38 years with sonographically diagnosed adenomyosis scheduled for single blastocyst FET. This study is designed as a superiority trial. Recruitment will be conducted by trained clinical research coordinators. Participants are randomized in a 1:1:1:1 ratio to four arms: one dose of GnRH-a (3.75 mg), two doses of GnRH-a, one dose of GnRH-a with letrozole (2.5 mg daily for 28 days), or two doses of GnRH-a with letrozole (2.5 mg daily for 28 days). The primary outcome is live birth rate. Secondary outcomes include fertility outcomes, pregnancy and obstetric outcomes, and neonatal outcomes. Safety outcomes, including the incidence and severity of low-estrogen-related adverse events (e.g., hot flashes, bone loss, vaginal dryness) and other serious adverse events, will be collected and compared. An internal pilot phase will assess procedural feasibility when approximately 25 participants are randomized per arm. Data are collected via medical records and follow-up assessments up to 6 months postpartum.

DISCUSSION: This factorial RCT is the first to assess the synergistic effects of GnRH-a dosage and letrozole supplementation, overcoming limitations of single-factor studies. By comprehensively evaluating pregnancy outcomes, the study aims to optimize pretreatment strategies, inform clinical guidelines, and improve pregnancy outcomes for adenomyosis patients undergoing FET.

TRIAL REGISTRATION: ClinicalTrials.gov NCT07065539. Registered on 14 July 2025. https://clinicaltrials.gov/study/NCT07065539. The first participant was enrolled in August 2025.

PMID:42032741 | DOI:10.1186/s13063-026-09731-2

J Cardiothorac Surg. 2026 Apr 24. doi: 10.1186/s13019-026-04235-1. Online ahead of print.

ABSTRACT

BACKGROUND: The increasing detection of pulmonary nodules through low-dose computed tomography screening has necessitated precise preoperative localization techniques. While local anesthesia is routinely used for CT-guided pulmonary nodule localization, it inadequately addresses deep tissue pain during pleural penetration. This study is to evaluate the analgesic efficacy and safety of ultrasound-guided erector spinae plane block (ESPB) during CT-guided pulmonary nodule localization.

METHODS: This single-center, prospective, randomized controlled trial was conducted from June 2024 to January 2025, enrolling 82 patients undergoing preoperative CT-guided pulmonary nodule localization. Participants were randomly assigned to either control group (local anesthesia with 4 ml 1% lidocaine) or ESPB group (ultrasound-guided ESPB with 20 ml 0.375% ropivacaine plus local anesthesia). The primary outcome was numerical rating scale (NRS) score during pleural penetration. Secondary outcomes included anxiety levels, radiation exposure, procedural time, hemodynamic parameters, pneumothorax incidence, and patient satisfaction. Statistical analysis was performed using independent-sample t-test and Mann-Whitney U test.

RESULTS: The ESPB group demonstrated significantly lower NRS scores during pleural penetration compared to the control group (2.68 ± 1.52 vs. 5.17 ± 1.32). Patients receiving ESPB exhibited reduced preoperative anxiety (44.71 ± 3.45 vs. 50.63 ± 3.74), decreased radiation exposure (401.06 ± 266.01 vs. 875.36 ± 377.45 mGy*cm), shorter fluoroscopy time (55.10 ± 10.54 vs. 117.39 ± 20.68 s, ), and lower pneumothorax incidence (4.88% vs. 19.51%), all P < 0.05. Post-procedural comfort scores and patient satisfaction were significantly higher in the ESPB group.

CONCLUSIONS: Ultrasound-guided ESPB improves analgesia, reduces anxiety, radiation exposure and complications while enhancing patient satisfaction during CT-guided pulmonary nodule localization, representing a valuable adjunct for thoracic interventional procedures.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06441071, registered May 8, 2024.

PMID:42032730 | DOI:10.1186/s13019-026-04235-1

Acta Neuropathol Commun. 2026 Apr 24;14(1):101. doi: 10.1186/s40478-026-02240-y.

NO ABSTRACT

PMID:42032706 | DOI:10.1186/s40478-026-02240-y

Environ Health. 2026 Apr 24. doi: 10.1186/s12940-026-01297-5. Online ahead of print.

NO ABSTRACT

PMID:42032672 | DOI:10.1186/s12940-026-01297-5

Arthritis Res Ther. 2026 Apr 24. doi: 10.1186/s13075-026-03815-9. Online ahead of print.

NO ABSTRACT

PMID:42032665 | DOI:10.1186/s13075-026-03815-9

BMC Med. 2026 Apr 24. doi: 10.1186/s12916-026-04831-x. Online ahead of print.

ABSTRACT

BACKGROUND: Transparency in randomized controlled trials (RCTs) has substantially improved in recent years, notably through trial registration and public availability of protocols and statistical analysis plans (SAPs). However, the reporting of protocol and SAPs modifications remains insufficiently standardized. As a result, even when these documents are publicly available, it is often challenging and time-consuming to identify what changes were made, why they were implemented, and whether they may affect the trustworthiness of the trial results.

ARGUMENTS: In this paper, we advocate for the development of a consensus-based framework for protocol modifications in RCTs. This need arises from the inherent tension between the necessity and the risks of protocol modifications. On the one hand, such modifications are often essential to address unforeseen operational, scientific, or ethical challenges. On the other hand, they may introduce bias and undermine confidence in trial findings, particularly when changes are data-driven or insufficiently justified. Although major transparency initiatives have strengthened trial reporting, important gaps persist. We review empirical evidence demonstrating the prevalence and nature of such modifications and discuss their potential implications for the validity, interpretation, and credibility of trial findings. Furthermore, readers, reviewers, and decision-makers face substantial challenges in identifying, understanding, and evaluating the potential impact of protocol changes. In the absence of standardized reporting, key information remains dispersed across multiple documents, placing an unreasonable burden on stakeholders to identify, interpret, and assess protocol modifications and their implications for the credibility of trial results.

CONCLUSIONS: Standardized and transparent reporting of protocol modifications is essential to ensure that their nature, timing, and rationale can be clearly understood and critically evaluated. We therefore advocate for the development of a consensus-based reporting framework, informed by a Delphi process, to improve transparency, facilitate critical appraisal, and strengthen confidence in RCT findings.

PMID:42032663 | DOI:10.1186/s12916-026-04831-x

Fluids Barriers CNS. 2026 Apr 24. doi: 10.1186/s12987-026-00803-8. Online ahead of print.

ABSTRACT

OBJECTIVE: Cerebrospinal fluid (CSF) over-drainage is an unintended sequela of using a shunt valve to treat hydrocephalus, and a second valve may be added in series to better control drainage. In this study, we tested whether the opening pressures of two valves in series-Codman Hakim ball valve (HBV) and the Miethke M.blue^Ⓡ adjustable gravitational valve (AGV)-can be treated as being additive using a novel in vitro benchtop model.

METHODS: Six dual-valve circuits were tested in triplicates for different combinations of HBV and AGV settings adding up to a summed opening pressure (OP) of either 20 or 40 cmH₂O. This “theoretical” sum was based on the addition of the nominal OP settings as stated by the manufacturer. Kruskal-Wallis tests and linear mixed-effect models were employed to analyze the flow rates for HBV-AGV settings with the same theoretical OP.

RESULTS: Kruskal-Wallis analysis demonstrated that HBV-AGV settings for each circuit, at a theoretical OP of 20 and 40 cmH₂O, showed statistically significant differences in flow rate. In linear mixed-effects models, as HBV OP was increased and composed a larger fraction of the theoretical OP, the flow rate decreased (effect size: -1.567 × 10^{– 3} mL/min/cmH₂O, standard error: 1.663 × 10^{– 4} mL/min/cmH₂O, p < 2 × 10^{– 16} at 20 cmH₂O, and effect size: -3.735 × 10^{– 3} mL/min/cmH₂O, standard error: 1.475 × 10^{– 4} mL/min/cmH₂O, p < 2 × 10^{– 16} at 40 cmH₂O, respectively).

CONCLUSION: An analysis of the flow data demonstrated statistically significant differences between combinations of HBV-AGV settings adding up to the same theoretical opening pressure. These findings suggest that in practice, the nominal OPs of Hakim and M.blue^Ⓡ valves may not be additive. Clinicians should be aware that drainage patterns can change when adjusting OPs of Hakim^Ⓡ and M.blue^Ⓡ valves under the assumption that HBV-AGV settings with the same summed theoretical OP behave alike.

PMID:42032645 | DOI:10.1186/s12987-026-00803-8

BMC Oral Health. 2026 Apr 24. doi: 10.1186/s12903-026-08355-x. Online ahead of print.

NO ABSTRACT

PMID:42032633 | DOI:10.1186/s12903-026-08355-x