Category: Statistics

J Endod. 2023 Aug 14:S0099-2399(23)00496-X. doi: 10.1016/j.joen.2023.08.006. Online ahead of print.

ABSTRACT

INTRODUCTION: To compare the biofilm-mimicking hydrogel removal efficiency of Laser-activated irrigation (LAI, AdvErl Evo, Morita) with five other irrigation techniques in simulated curved root canals with lateral canals.

METHODS: 3D-printed root canal models (60°-curvature, radius 5mm; dimension 25/.06) with a total length of 20mm and lateral canals in all directions at 2, 5 and 8mm (diameter 0.2mm) from the apex were filled with a colored biofilm-mimicking hydrogel. The following protocols (each 3x20s continuous irrigation with distilled water 3ml/20s; n=20) were carried out: conventional needle irrigation (=NI); manual agitation (=MA, gutta-percha point 25/.06); EndoActivator (=SAI-EA, 25/.04); EDDY (=SAI-E; 25/.04); ultrasonically-activated irrigation (=UAI) and LAI (Er:YAG-laser; P400FL tip at canal entrance; 25pps, 50mJ, 300μs). Standardized photos were taken with a microscope and the removal of the hydrogel was determined as a percentage for the entire system, the main canal and the lateral canals. Statistical analysis was performed using ANOVA and Scheffé test (P=.05).

RESULTS: LAI (89.3±5.9%) showed the greatest hydrogel removal followed by SAI-E (65.5±3.3%) and UAI (59.1±4.7%), with significant differences between these groups (P<.05). NI, MA and SAI-EA performed equally (P>.05) and obtained the significantly lowest values (P<.05). LAI and SAI-E showed the significantly best hydrogel removal from the main canal (P<.05). At all three levels, LAI removed significantly more hydrogel from the lateral canals than all other techniques (P<.05).

CONCLUSION: LAI was superior to other techniques in both the entire system and the lateral canals in removing the hydrogel. SAI-E achieved comparable results in the main canal.

PMID:37586645 | DOI:10.1016/j.joen.2023.08.006

Int J Radiat Oncol Biol Phys. 2023 Aug 14:S0360-3016(23)07744-1. doi: 10.1016/j.ijrobp.2023.07.046. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the benefit of an intensive locoregional treatment including an image-guided adaptive brachytherapy (IGABT) among cervical cancer patients with extrapelvic extension.

PATIENTS AND METHODS: Medical records of consecutive patients with a metastatic cervical cancer and receiving an external beam radiotherapy (EBRT) and IGABT boost in XXXXXX XXXXXX as part of their first line of treatment were examined. Depending on tumor sites, patients received a pelvic +/- para-aortic EBRT. For those with visceral or supradiaphragmatic lymph node metastases, chemoradiation was delivered after usually 3 cycles of chemotherapy. All patients received a brachytherapy boost, guided by magnetic resonance imaging and aimed at increasing the dose to the high risk clinical target volume (CTV_HR). Local control, patient overall (OS), progression-free (PFS) survival and radiotherapy-related side effects were examined and prognostic factors were searched.

RESULTS: 164 patients were included, 76.2% had para-aortic lymph node extension without distant metastasis (N2) and 23.8% had distant metastatic sites (M1). There was not statistically significant difference in survival between both groups. With a median follow-up of 36 months, OS, PFS, and LC at 3 years were 55.5% (CI95%: 48-64), 40.6% (CI95%: 38-54), and 90% (CI95%: 85-96), respectively. In multivariate analysis, a D₉₀CTV_HR dose ≥80 Gy was significant for better OS (HR=0.96, 95%CI: 0.94-0.98, p<0.001). Most toxicities were mild to moderate, with 2% of grade 3 late urinary toxicity, 7% late grade 2 vaginal sequelae, and one grade 3 proctitis. During follow-up, rectovaginal fistula occurred in two patients without local relapse.

CONCLUSION: IGABT permits dose escalation and high LC rates for cervical cancer patients with extrapelvic extension. Dose/effect relationships for survival were shown. Because of high frequency of distant events, systemic intensification should be tested more specifically among these patients.

PMID:37586615 | DOI:10.1016/j.ijrobp.2023.07.046

Int J Radiat Oncol Biol Phys. 2023 Aug 14:S0360-3016(23)07747-7. doi: 10.1016/j.ijrobp.2023.08.009. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to define the minimal clinically important difference (MCID) for the FACT Hepatobiliary (FACT-Hep) questionnaire, allowing meaningful evaluation of the effect of radiotherapy (RT) on quality of life (QOL) in patients treated for pancreatic cancer (PC).

METHODS AND MATERIALS: The cohort included patients with PC who received RT as a component of curative intent therapy, who completed the FACT-Hep at baseline and end of treatment (EOT). The MCID was determined for the FACT-Hep and subdomains using anchor-based and distribution-based approaches. In the anchor-based approach, improvement and deterioration in age-adjusted regression models for change in scores were defined using the overall health assessment item of the PROMIS-10 as the anchor. The MCID was calculated as 0.3 and 0.5 standard deviation (SD) for distribution-based analysis. MCID point estimate using 0.5 SD (range) was averaged across time points and by approach, and the ranges are reported as minimum and maximum values across methods.

RESULTS: The FACT-Hep domain with the lowest MCID was the emotional domain (deterioration 0.8-1.8). The hepatobiliary cancer subscale (HCS) has the highest and widest MCID range. A positive change of 2.9-4.3 in HCS should be considered a clinically relevant improvement. MCID estimates from 0.3 SD were in exact agreement with the anchor-based estimates for the physical domain (1.6-2.4). The MCID range for the Fact-Hep total score was 6.9-10.5 and 6.5-10.5 for improvement and deterioration, respectively.

CONCLUSION: The MCID for the FACT-Hep subdomains and totals were calculated using a combination of anchor- and distribution-based approaches. These findings are fundamental to determine whether there is meaningful improvement or deterioration in QOL for patients with PC receiving RT. Evaluating a different anchor for determining the MCID of the social domain is recommended.

PMID:37586614 | DOI:10.1016/j.ijrobp.2023.08.009

J Arthroplasty. 2023 Aug 14:S0883-5403(23)00825-2. doi: 10.1016/j.arth.2023.08.028. Online ahead of print.

ABSTRACT

INTRODUCTION: We aimed to determine if the use of augmented tibial fixation with stems in primary total knee arthroplasty (TKA) in obese patients was associated with a difference in the reason for revision, type of revision, or the overall revision rate.

METHODS: Data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) compared reason for revision, rate, and type of revision between primary TKA using stemmed tibial prostheses to non-stemmed prostheses, stratified by body mass index (BMI) and obesity. The cumulative percent revision (CPR) was obtained using the Kaplan-Meier method, and Cox proportional hazards models estimated hazard ratios (HRs) adjusted for age and sex, with 95% confidence intervals. All tests were two-tailed at 5% statistical significance (P<0.05). P values are capitalized and italicized throughout the manuscript and tables. There were 66,508 procedures were available for analyses.

RESULTS: Obese Class 2 (BMI 35 to 39.99) had higher rates of revision in the stemmed group compared to the no stem group (Hazards Ratio (HR) 1.44, 95% Confidence Interval (CI) 1.00, 2.05, P=0.047). There was no significant difference in revision rates between stemmed and non-stemmed tibial prostheses in any other BMI group. Primary TKA in obese patients (BMI ≥30), with a stem extension had a significantly higher rate of minor revisions compared to no stem extension (HR 1.31 95% CI 1.03, 1.66, P=0.025). There was no significant difference between stemmed and no stem groups for major revision in obese patients, and for minor or major revision in non-obese patients.

CONCLUSION: Using a tibial stem during primary TKA in obese patients is not associated with a lower rate of revision.

PMID:37586598 | DOI:10.1016/j.arth.2023.08.028

J Arthroplasty. 2023 Aug 14:S0883-5403(23)00823-9. doi: 10.1016/j.arth.2023.08.027. Online ahead of print.

ABSTRACT

BACKGROUND: The noise associated with ceramic-on-ceramic (CoC) total hip arthroplasty (THA) has been a concerning issue, while its underlying causes remain unclear.

METHODS: We conducted a retrospective analysis of 119 patients (174 primary CoC THAs) who had a mean follow-up of 28 months (range, 12 to 106). A questionnaire was designed to collect information on nature, frequency, onset, duration, and impact of the noise. Post-operative x-rays were evaluated. Clinical evaluations, including Harris and Oxford hip scores, were documented at follow-up time points (6 weeks, 3 months, 6 months, and 1 year).

RESULTS: Of the 174 hips, 31.6% reported noise, including 26 popping (14.9%), 24 clicking (12.1%), and 5 grinding (2.9%). No patients reported squeaking. Noisy hips had lower age (P=0.009) and body mass index (P=0.019). Among developmental dysplasia of the hip patients, 17 of 55 hips reported noise associated with smaller cup anteversion angle (P=0.004), greater body height (P=0.022), and larger acetabular cup size (P=0.049). Noise typically began at a mean of 193 days (range, 1 to 2,598) days after surgery and disappeared spontaneously in 50.9% of hips before final follow-up, with an average disappearance time of 211 days (range, 60 to 730) days. Noise did not affect daily life in 74.5% of patients, while 26.9% of patients who had popping reported painful sensations. One patient experienced joint dislocation, and another experienced a ceramic liner fracture during follow-up. No statistical difference was observed in outcome scores between noise and silent groups at four follow-up time points.

CONCLUSION: Incidence of noise after primary CoC THA is relatively high. Smaller cup anteversion and larger acetabular cup size were associated with noise production in patients who had DDH.

PMID:37586597 | DOI:10.1016/j.arth.2023.08.027

Am J Cardiol. 2023 Aug 14;205:63-68. doi: 10.1016/j.amjcard.2023.07.162. Online ahead of print.

ABSTRACT

Coronary artery ectasia (CAE) is defined as local or generalized aneurysmal dilatation of the coronary arteries. CAE likely represents an exaggerated form of excessive vascular wall remodeling in different clinical settings such as atherosclerosis, vasculitides, connective tissue disorders, hereditary collagen defects, bacterial infections, and congenital malformations. In the present case-control study, we investigated whether the incidental finding of CAE in patients who undergo coronary angiography is associated with presence of autoimmune reactivity. From 2019 to 2022, we identified all consecutive patients with CAE (n = 319) on elective or emergency coronary angiography (n = 7,458). We furthermore included 90 patients with nonectatic coronary arteries as a control group. Antinuclear antibody (ANA) titer was measured in both groups using the indirect immunofluorescence method from peripheral blood samples. The prevalence of CAE in our study cohort was 4.3%. Among patients with CAE (n = 319), presence of positive Antinuclear antibody (ANA) titer was identified in 128 patients (40%). Only 18 patients (20%) from the control group had positive ANA titer. There was a statistically significant greater percentage of patients with positive ANA titer among patients with CAE than among controls (chi-square = 12.39; p <0.001), with an odds ratio of 2.68. Among patients with CAE, there is an increased prevalence of positive ANA titer, suggesting an underlying autoimmune disease. Screening for autoimmune reactivity could be a reasonable diagnostic strategy in patients who undergo coronary angiography with an incidental finding of coronary ectasia because the number needed to screen for positive ANA titer in this subgroup of patients is only 5.

PMID:37586123 | DOI:10.1016/j.amjcard.2023.07.162

J Crohns Colitis. 2023 Aug 16:jjad138. doi: 10.1093/ecco-jcc/jjad138. Online ahead of print.

ABSTRACT

BACKGROUND & AIMS: Randomized controlled trials historically underrepresent marginalized racial and ethnic populations. As incidence and prevalence of Crohn’s Disease in these groups rises, it is important to characterize their inclusion in randomized controlled trials on first-line and pipe-line medications.

METHODS: PubMed was searched systematically for randomized controlled trials of biologic and small molecule inhibitor (SMI) medications with a primary outcome related to efficacy following PRISMA guidelines. We used descriptive statistics to summarize demographic variables and meta-regression analyses to estimate temporal trends in racial inclusion.

RESULTS: More than a half of trials did not report any racial/ethnic demographics (53.7%) and several reported racial demographics for only one race (20.9%). When racial data was reported, Whites made up 90.2% of participants. Percentages of Black, Asian, Native American/Pacific Islander and participants considered “Other” averaged 2.9%, 11.6%, 0.5% and 1.6%, out of the total sample sizes of 3,901, 3,742, 828 and 4,027, respectively. Proportional representation of White participants decreased over time (p<0.01), while proportional representation of Asian participants increased over time (p=0.047). In ordinal logistic regression, mean year of trial enrollment significantly increased the number of racial groups reported (p<0.001).

CONCLUSIONS: Half of published randomized controlled trials in Crohn’s Disease contain no racial or ethnic demographics and the remaining often only have limited inclusion of Black, Native American/Pacific Islander and Hispanic patients. Further work should characterize representation in observational and prospective trials. Researchers should work to 1) increase reporting of racial and ethnic demographics and 2) improve recruitment and retention of marginalized populations.

PMID:37586091 | DOI:10.1093/ecco-jcc/jjad138

J Physician Assist Educ. 2023 Aug 15. doi: 10.1097/JPA.0000000000000528. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this novel study was to determine whether any association exists between student well-being and physician assistant (PA) program approaches to teaching provider health and well-being (provider wellness).

METHODS: Data were sourced from 3 PA Education Association surveys. Data from the 2019 Matriculating Student and End of Program Surveys (EOPS) were analyzed to compare student-reported well-being across 6 measures. Next, data from the 2019 Didactic Curriculum Survey were assessed and matched to the 2019 EOPS data. Finally, generalized estimating equation models were used to assess the independent effects of course structure, mode of instruction, and contact hours on well-being scores among end-of-program students (within one month of graduation).

RESULTS: While levels of well-being were generally favorable, except for “level of social activity” (P = .20), across measures, graduating student levels of well-being (P < .05) were statistically significantly lower than matriculating student levels of well-being. No associations were found between levels of student well-being and whether programs reported teaching or not teaching provider wellness. Some aspects of instruction (eg, contact hours) were inconsistently associated with various well-being measures.

CONCLUSION: In this study, no consistent associations between approaches to teaching provider wellness and various measures of student well-being were identified. Further research is needed to determine what approaches to promoting wellness are effective.

PMID:37586068 | DOI:10.1097/JPA.0000000000000528

J Vasc Access. 2023 Aug 10:11297298231186374. doi: 10.1177/11297298231186374. Online ahead of print.

ABSTRACT

BACKGROUND: YouTube™ has become a potential way to integrate technology into nursing curriculum and acquire skills. However, it is important to review the accuracy of the information contained in YouTube™. This study was conducted to evaluate the content validity, reliability and quality of YouTube™ videos on peripheral intravenous catheterization.

METHODS: In this descriptive study, videos were searched using the keyword ‘Peripheral Venous Catheter’. The content validity, reliability and quality of the videos were evaluated using the ‘Peripheral Intravenous Catheterization Insertion Skill Form’, ‘DISCERN Questionnaire’, ‘Global Quality Scale’, respectively. These videos were categorized by their theme, upload source, technical features and analysed statistically.

RESULTS: Of the 48 videos, 38 (79.2%) classified as an useful video, 24 (50%) were uploaded by medical educational platforms and 28 (58.3%) had an average technical feature. There was a statistically significant difference between the reliability, quality, content validity scores by the video theme (p < 0.05). The content validity, reliability and quality score of useful videos were higher than misleading videos. In addition, pairwise comparisons indicated that there was a statistically significant difference between the content validity, reliability and quality scores of Peripheral Intravenous Catheterization demonstrated on a person or a mannequin were higher than those applied with ultrasonography (p < 0.05).

CONCLUSIONS: As a result of the reviewing of the videos, it was determined that these videos provided useful content. Despite this positive result, some videos provide risky information for patient safety due to issues such as ignoring the asepsis principles and not including proper Peripheral Intravenous Catheterization steps. It may be recommended to consider the Peripheral Intravenous Catheterization steps and patient safety principles in international guidelines in the preparation of videos showing the Peripheral Intravenous Catheterization insertion.

PMID:37586014 | DOI:10.1177/11297298231186374

Rev Assoc Med Bras (1992). 2023 Aug 14;69(8):e20230316. doi: 10.1590/1806-9282.20230316. eCollection 2023.

ABSTRACT

OBJECTIVE: This study aimed to evaluate the quality of life of patients with endometriosis before and after surgical treatment.

METHODS: An observational, longitudinal, and prospective study was conducted with 102 women with pelvic pain and endometriosis that was unimproved by clinical treatment and indicated for surgical treatment. The patients’ quality of life was assessed using the 30-item Endometriosis Health Profile (EHP-30) questionnaire before and 3 and 6 months after surgery. The statistical tests were analyzed using the Statistical Package for Social Sciences version 17.0, and the Friedman test was used.

RESULTS: There was a reduction in EHP-30 scores 3 and 6 months after surgery compared to before surgery, as well as 6 months after surgery compared to 3 months after surgery, in the central questionnaire (PART 1) and in Sections A, B, C, E, and F (p<0.0001). For Section D, there was a reduction in scores 6 months after surgery compared to before surgery (p<0.0001).

CONCLUSION: Surgical treatment of endometriosis improves quality of life in several areas assessed by the EHP-30 questionnaire.

PMID:37585993 | DOI:10.1590/1806-9282.20230316