Tag: statistics

Br J Sports Med. 2023 Jul 6:bjsports-2023-106948. doi: 10.1136/bjsports-2023-106948. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the effectiveness of patient advice plus heel cup alone (PA) versus PA and lower limb exercise (PAX) versus PAX plus corticosteroid injection (PAXI) to improve self-reported pain in patients with plantar fasciopathy.

METHODS: We recruited 180 adults with plantar fasciopathy confirmed by ultrasonography for this prospectively registered three-armed, randomised, single-blinded superiority trial. Patients were randomly allocated to PA (n=62), PA plus self-dosed lower limb heavy-slow resistance training consisting of heel raises (PAX) (n=59), or PAX plus an ultrasound-guided injection of 1 mL triamcinolone 20 mg/mL (PAXI) (n=59). The primary outcome was changed in the pain domain of the Foot Health Status Questionnaire (ranging from 0 ‘worst’ to 100 ‘best’) from baseline to the 12-week follow-up. The minimal important difference in the pain domain is 14.1 points. The outcome was collected at baseline and at 4, 12, 26, and 52 weeks.

RESULTS: The primary analysis found a statistically significant difference between PA and PAXI after 12 weeks favouring PAXI (adjusted mean difference: -9.1 (95% CI -16.8 to -1.3; p=0.023)) and over 52 weeks (adjusted mean difference: -5.2 (95% CI -10.4 to -0.1; p=0.045)). At no follow-up did the mean difference between groups exceed the pre-specified minimal important difference. No statistically significant difference was found between PAX and PAXI or between PA and PAX at any time.

CONCLUSION: No clinically relevant between-group differences were found after 12 weeks. The results indicate that combining a corticosteroid injection with exercise is not superior to exercise or no exercise.

TRIAL REGISTRATION NUMBER: NCT03804008.

PMID:37414460 | DOI:10.1136/bjsports-2023-106948

AJNR Am J Neuroradiol. 2023 Jul 6. doi: 10.3174/ajnr.A7923. Online ahead of print.

ABSTRACT

BACKGROUND: Platelet function testing has been proposed to better adjust individualized antiplatelet treatment for patients undergoing endovascular treatment for intracranial aneurysms. Its clinical significance needs to be comprehensively evaluated.

PURPOSE: Our aim was to evaluate the impact of platelet function testing-guided versus standard antiplatelet treatment in patients receiving endovascular treatment for intracranial aneurysms.

DATA SOURCES: PubMed, EMBASE, and the Cochrane Library of clinical trials were searched from inception until March 2023.

STUDY SELECTION: Eleven studies comprising 6199 patients were included.

DATA ANALYSIS: ORs with 95% CIs were calculated using random effects models.

DATA SYNTHESIS: The platelet function testing-guided group was associated with a decreased rate of symptomatic thromboembolic events (OR = 0.57; 95% CI, 0.42-0.76; I² = 26%). No significant difference was found in asymptomatic thromboembolic events (OR = 1.07; 95% CI, 0.39-2.94; I² = 48%), hemorrhagic events (OR = 0.71; 95% CI, 0.42-1.19; I² = 34%), intracranial hemorrhagic events (OR = 0.61; 95% CI, 0.03-10.79; I² = 62%), morbidity (OR = 0.53; 95% CI, 0.05-5.72; I² = 86%), and mortality (OR = 1.96; 95% CI, 0.64-5.97; I² = 0%) between the 2 groups. Subgroup analysis suggested that platelet function testing-guided therapy may contribute to fewer symptomatic thromboembolic events in patients who received stent-assisted coiling (OR = 0.43; 95% CI, 0.18-1.02; I² = 43%) or a combination of stent-assisted and flow-diverter stent placement (OR = 0.61; 95% CI, 0.36-1.02; I² = 0%) or who changed from clopidogrel to other thienopyridines (OR = 0.64; 95% CI, 0.40-1.02; I² = 18%), though the difference did not reach statistical significance.

LIMITATIONS: Heterogeneous endovascular treatment methods and adjusted antiplatelet regimens were limitations.

CONCLUSIONS: Platelet function testing-guided antiplatelet strategy significantly reduced the incidence of symptomatic thromboembolic events without any increase in the hemorrhagic events for patients undergoing endovascular treatment for intracranial aneurysms.

PMID:37414457 | DOI:10.3174/ajnr.A7923

AJNR Am J Neuroradiol. 2023 Jul 6. doi: 10.3174/ajnr.A7935. Online ahead of print.

ABSTRACT

BACKGROUND: Transophthalmic artery embolization of intracranial meningiomas is thought to be associated with a high complication risk.

PURPOSE: With advances in endovascular techniques, we systematically reviewed the current literature to improve our understanding of the safety and efficacy of transophthalmic artery embolization of intracranial meningiomas.

DATA SOURCES: We performed a systematic search using PubMed from inception until August 3, 2022.

STUDY SELECTION: Twelve studies with 28 patients with intracranial meningiomas embolized through the transophthalmic artery were included.

DATA ANALYSIS: Baseline and technical characteristics and clinical and safety outcomes were collected. No statistical analysis was conducted.

DATA SYNTHESIS: The average age of 27 patients was 49.5 (SD, 13) years. Eighteen (69%) meningiomas were located in the anterior cranial fossa, and 8 (31%), in the sphenoid ridge/wing. Polyvinyl alcohol particles were most commonly (n = 8, 31%) used to preoperatively embolize meningiomas, followed by n-BCA in 6 (23%), Onyx in 6 (23%), Gelfoam in 5 (19%), and coils in 1 patient (4%). Complete embolization of the target meningioma feeders was reported in 8 (47%) of 17 patients; partial embolization, in 6 (32%); and suboptimal embolization, in 3 (18%). The endovascular complication rate was 16% (4 of 25), which included visual impairment in 3 (12%) patients.

LIMITATIONS: Selection and publication biases were limitations.

CONCLUSIONS: Transophthalmic artery embolization of intracranial meningiomas is feasible but is associated with a non-negligible complication rate.

PMID:37414456 | DOI:10.3174/ajnr.A7935

AJNR Am J Neuroradiol. 2023 Jul 6. doi: 10.3174/ajnr.A7937. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Automatic brain parcellation is typically performed on dedicated MR imaging sequences, which require valuable examination time. In this study, a 3D MR imaging quantification sequence to retrieve R₁ and R₂ relaxation rates and proton density maps was used to synthesize a T1-weighted image stack for brain volume measurement, thereby combining image data for multiple purposes. The repeatability and reproducibility of using the conventional and synthetic input data were evaluated.

MATERIALS AND METHODS: Twelve subjects with a mean age of 54 years were scanned twice at 1.5T and 3T with 3D-QALAS and a conventionally acquired T1-weighted sequence. Using SyMRI, we converted the R₁, R₂, and proton density maps into synthetic T1-weighted images. Both the conventional T1-weighted and the synthetic 3D-T1-weighted inversion recovery images were processed for brain parcellation by NeuroQuant. Bland-Altman statistics were used to correlate the volumes of 12 brain structures. The coefficient of variation was used to evaluate the repeatability.

RESULTS: A high correlation with medians of 0.97 for 1.5T and 0.92 for 3T was found. A high repeatability was shown with a median coefficient of variation of 1.2% for both T1-weighted and synthetic 3D-T1-weighted inversion recovery at 1.5T, and 1.5% for T1-weighted imaging and 4.4% for synthetic 3D-T1-weighted inversion recovery at 3T. However, significant biases were observed between the methods and field strengths.

CONCLUSIONS: It is possible to perform MR imaging quantification of R₁, R₂, and proton density maps to synthesize a 3D-T1-weighted image stack, which can be used for automatic brain parcellation. Synthetic parameter settings should be reinvestigated to reduce the observed bias.

PMID:37414454 | DOI:10.3174/ajnr.A7937

Eur Heart J. 2023 Jul 6:ehad269. doi: 10.1093/eurheartj/ehad269. Online ahead of print.

ABSTRACT

AIMS: To develop a healthy diet score that is associated with health outcomes and is globally applicable using data from the Prospective Urban Rural Epidemiology (PURE) study and replicate it in five independent studies on a total of 245 000 people from 80 countries.

METHODS AND RESULTS: A healthy diet score was developed in 147 642 people from the general population, from 21 countries in the PURE study, and the consistency of the associations of the score with events was examined in five large independent studies from 70 countries. The healthy diet score was developed based on six foods each of which has been associated with a significantly lower risk of mortality [i.e. fruit, vegetables, nuts, legumes, fish, and dairy (mainly whole-fat); range of scores, 0-6]. The main outcome measures were all-cause mortality and major cardiovascular events [cardiovascular disease (CVD)]. During a median follow-up of 9.3 years in PURE, compared with a diet score of ≤1 points, a diet score of ≥5 points was associated with a lower risk of mortality [hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.63-0.77)], CVD (HR 0.82; 0.75-0.91), myocardial infarction (HR 0.86; 0.75-0.99), and stroke (HR 0.81; 0.71-0.93). In three independent studies in vascular patients, similar results were found, with a higher diet score being associated with lower mortality (HR 0.73; 0.66-0.81), CVD (HR 0.79; 0.72-0.87), myocardial infarction (HR 0.85; 0.71-0.99), and a non-statistically significant lower risk of stroke (HR 0.87; 0.73-1.03). Additionally, in two case-control studies, a higher diet score was associated with lower first myocardial infarction [odds ratio (OR) 0.72; 0.65-0.80] and stroke (OR 0.57; 0.50-0.65). A higher diet score was associated with a significantly lower risk of death or CVD in regions with lower than with higher gross national incomes (P for heterogeneity <0.0001). The PURE score showed slightly stronger associations with death or CVD than several other common diet scores (P < 0.001 for each comparison).

CONCLUSION: A diet comprised of higher amounts of fruit, vegetables, nuts, legumes, fish, and whole-fat dairy is associated with lower CVD and mortality in all world regions, especially in countries with lower income where consumption of these foods is low.

PMID:37414411 | DOI:10.1093/eurheartj/ehad269

Trop Med Int Health. 2023 Jul 6. doi: 10.1111/tmi.13909. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the association between Highly Active Antiretroviral Therapy (HAART) discontinuation time and therapeutic failure (TF) in Venezuelan immigrants with HIV that restart HAART.

METHODS: We carried out a retrospective cohort study in a large hospital in Peru. We included Venezuelan immigrants who restarted HAART and were followed over at least 6 months. The primary outcome was TF. Secondary outcomes were immunologic (IF), virologic (VF) and clinical (CF) failures. The exposure variable was HAART discontinuation, categorised as no discontinuation, less than 6 months, and 6 months or more. We applied generalised linear models Poisson family with robust standard errors to calculate crude (cRR) and adjusted (aRR) relative risks by statistical and epidemiological criteria.

RESULTS: We included 294 patients, 97.2% were males, and the median age was 32 years. Out of all the patients, 32.7% discontinued HAART for less than 6 months, 15.0% discontinued for more than 6 months and the remaining 52.3% did not discontinue. The cumulative incidence of TF was 27.9%, 24.5% in VF, 6.0% in IF and 6.0% in CF. Compared with non-discontinued HAART patients, the discontinuation for less than 6 months (aRR = 1.98 [95% CI: 1.27-3.09]) and from 6 months to more (aRR = 3.17 [95% CI: 2.02-4.95]) increased the risk of TF. Likewise, treatment discontinuation of up to 6 months (aRR = 2.32 [95% CI: 1.40-3.84]) and from 6 months to more (aRR = 3.93 [95% CI: 2.39-6.45]) increased the risk of VF.

CONCLUSIONS: HAART discontinuation increases the probability of TF and VF in Venezuelan immigrants.

PMID:37414409 | DOI:10.1111/tmi.13909

Kidney Int. 2023 Jul 4:S0085-2538(23)00472-6. doi: 10.1016/j.kint.2023.06.018. Online ahead of print.

ABSTRACT

Multiple genome-wide association studies (GWASs) have reproducibly identified the MTMR3/HORMAD2/LIF/OSM locus to be associated with IgA nephropathy (IgAN). However, the causal variant(s), implicated gene(s), and altered mechanisms remain poorly understood. Here, we performed fine-mapping analyses based on GWAS datasets encompassing 2762 IgAN cases and 5803 control individuals, and identified rs4823074 as the candidate causal variant that intersects the MTMR3 promoter in B-lymphoblastoid cells. Mendelian randomization studies suggested the risk allele may modulate disease susceptibility by affecting serum IgA levels through increased MTMR3 expression. Consistently, elevated MTMR3 expression in peripheral blood mononuclear cells was observed in patients with IgAN. Further mechanistic studies in vitro demonstrated that MTMR3 increased IgA production dependent upon its phosphatidylinositol 3-phosphate binding domain. Moreover, our study provided the in vivo functional evidence that Mtmr3-/- mice exhibited defective Toll Like Receptor 9-induced IgA production, glomerular IgA deposition, as well as mesangial cell proliferation. RNA-seq and pathway analyses showed that MTMR3 deficiency resulted in an impaired intestinal immune network for IgA production. Thus, our results support the role of MTMR3 in IgAN pathogenesis by enhancing Toll Like Receptor 9-induced IgA immunity.

PMID:37414396 | DOI:10.1016/j.kint.2023.06.018

J Dent. 2023 Jul 4:104603. doi: 10.1016/j.jdent.2023.104603. Online ahead of print.

ABSTRACT

OBJECTIVES: Adequate reporting of limitations is crucial to enable clinicians to accurately interpret the clinical trial findings. This meta-epidemiological study aimed to evaluate whether study limitations are reported in full-text articles of randomized controlled trials (RCTs) published in the leading dental journals. Associations between the trial characteristics and the reporting of limitations were also explored.

METHODS: RCTs published between 1^st January and 31^st December in the years 2011, 2016 and 2021 were identified from the 12 high impact factor dental journals (general and specialty). RCT characteristics were extracted, and reporting of limitations was recorded for the selected studies. Descriptive statistics were calculated for trial and limitations related characteristics. Univariable ordinal logistic regression models were fit to explore univariable associations between trial characteristics and reporting of limitations.

RESULTS: Two hundred and sixty-seven trials were included and analyzed. Most RCTs were published in 2021 (40.8%), had authors based in Europe (50.2%), did not have a statistician involved (88.8%) and assessed a procedure/method intervention type (40.5%). The reporting of trial limitations was generally sub-optimal. More recent trials and studies with a published protocol were associated with better reporting of limitations. The type of journal was a significant predictor for limitation reporting.

CONCLUSIONS: Within this study, the clear reporting of study limitations in the manuscripts of dental RCTs is sub-optimal and requires improvement.

CLINICAL SIGNIFICANCE: The reporting of limitations should not be viewed as a weakness of a trial but due diligence, so clinicians can fully interpret the impact of these limitations on both the validity and generalisability of the results.

PMID:37414393 | DOI:10.1016/j.jdent.2023.104603

J Thorac Oncol. 2023 Jul 4:S1556-0864(23)00639-1. doi: 10.1016/j.jtho.2023.06.018. Online ahead of print.

ABSTRACT

BACKGROUND: The role of family history of lung cancer (LCFH) in screening using low-dose computed tomography (LDCT) has not been prospectively investigated and with long-term follow-up.

METHODS: A multicenter prospective study with up to three rounds of annual LDCT screening was conducted to determine the detection rate of LC in asymptomatic first or second-degree relatives of LCFH.

RESULTS: From 2007 to 2011, there were 1,102 participants enrolled, including 805 and 297 from simplex (SF) and multiplex families (MF), respectively (54.2% female, and 70.0% never-smokers). Last follow-up date was May 05, 2021. The overall LC detection rate was 4.5% (50/1102). The detection rate in MF was 9.4% (19/202) and 4.4% (4/91) in never-smokers and who smoked, respectively. The corresponding rates for SF were 3.7% (21/569) and 2.7% (6/223), respectively. Of them, 68.0% and 22.0% of cases with stage I and IV diseases, respectively. LC diagnoses within a 3-year interval from initial screening were younger, higher detection rate, and more stage I disease; thereafter, more stage III/IV disease and 66.7% (16/24) with negative or semi-positive nodules in initial CT scans. Within the 6-year interval, only maternal (modified rate ratio [RR]=4.46, 95% confidence interval [CI]=2.32-8.56) or maternal relative history of LC (modified RR=5.41, 95% CI=2.84-10.30) increased the risk of LC.

CONCLUSION: LCFH is a risk factor for LC, more in MF history, never-smokers, younger adults, and those with maternal relatives with LC. Randomized controlled trials are needed to confirm mortality benefit of LDCT screening in those with LCFH.

PMID:37414358 | DOI:10.1016/j.jtho.2023.06.018

Gynecol Obstet Fertil Senol. 2023 Jul 4:S2468-7189(23)00153-8. doi: 10.1016/j.gofs.2023.06.005. Online ahead of print.

NO ABSTRACT

PMID:37414341 | DOI:10.1016/j.gofs.2023.06.005