Tag: statistics

J Bone Joint Surg Am. 2021 Nov 1. doi: 10.2106/JBJS.21.00287. Online ahead of print.

ABSTRACT

BACKGROUND: We investigated the influence of sex on patient-reported outcomes preoperatively and following total ankle replacement and ankle arthrodesis.

METHODS: Patients who had undergone total ankle replacement or ankle arthrodesis for the treatment of end-stage ankle arthritis and who had ≥2 years of follow-up were identified from the Canadian Orthopaedic Foot and Ankle Society Prospective Ankle Reconstruction Database. Standard surgical techniques and implantation methods were followed, and STAR, Hintegra, Mobility, and Agility prostheses were used. Data were collected on patient demographics, revisions, secondary procedures, complications, Ankle Osteoarthritis Scale (AOS) scores, Short Form-36 (SF-36) scores, and expectations and satisfaction. Statistical analyses included 3-way repeated-measures analysis of variance (ANOVA) and multiple linear regression models controlling for inflammatory arthritis, age, preoperative scores, and surgery type.

RESULTS: The study included 872 patients: 629 who had undergone total ankle replacement (316 men, 313 women) and 243 who had undergone ankle arthrodesis (154 men, 89 women). The mean duration of follow-up (and standard deviation) was 4.9 ± 2.4 and 4.0 ± 1.9 years for the total ankle replacement and ankle arthrodesis groups, respectively. Men were older than women (p ≤ 0.001). In both the total ankle replacement and ankle arthrodesis groups, women had higher AOS pain scores (i.e., more pain) than men preoperatively (p < 0.05). Pain was reduced significantly in both sexes postoperatively (p < 0.05), with no significant difference between sexes. In both the total ankle replacement and ankle arthrodesis groups, women had higher AOS disability scores (i.e., more disability) and lower SF-36 Physical Component Summary (PCS) scores (i.e., worse function) than men both preoperatively and postoperatively (p < 0.001). Postoperatively, AOS disability and SF-36 PCS scores improved significantly from baseline in both sexes (p < 0.001). After controlling for covariates, sex was not a significant predictor of postoperative SF-36 MCS (Mental Component Summary), AOS pain, or AOS disability scores (p > 0.05) but explained 0.5% of variance in SF-36 PCS scores (p = 0.03). Sex did not significantly influence preoperative expectations or postoperative satisfaction. When patients with inflammatory arthritis were excluded, preoperative and postoperative outcome measures, expectations, and satisfaction were similar.

CONCLUSIONS: Men and women with end-stage ankle arthritis benefited from total ankle replacement and ankle arthrodesis with similar magnitudes of improvement. Small differences in pain and function between men and women undergoing total ankle replacement and ankle arthrodesis mostly disappeared when controlling for potential confounding variables. Both total ankle replacement and ankle arthrodesis remain good options for men and women with end-stage ankle arthritis.

LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

PMID:35007215 | DOI:10.2106/JBJS.21.00287

J Drugs Dermatol. 2022 Jan 1;21(1):43-48. doi: 10.36849/JDD.2022.6492.

ABSTRACT

BACKGROUND: Fractional radiofrequency (FRF) technology has been shown in clinical studies to improve skin laxity, and to treat various skin conditions related to aging and alternate collagen structures such as rhytids. The objective of this clinical study was to evaluate the safety and performance of FRF (up to 124 mJ per pin) for the treatment of facial rhytids, emphasizing the upper lip and perioral areas.

METHODS: Enrolled subjects received a series of 3 FRF treatments to the full face, 3 to 5 weeks apart. Immediately after treatment, the subjects were given a scale to assess pain and tolerability of the treatment. Subject satisfaction questionnaires were completed at follow-up visits at 6 and 12 weeks post final treatment. Before and after photographs were graded for change by three blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale (FWES) and the Global Aesthetic Improvement Scale (GAIS).

RESULTS: Image sets of 10 enrolled subjects (average age 62.7 years) were assessed by blinded evaluators. The overall face FWES score improved from 5.97 (SE 0.20) at baseline to 5.78 (SE 0.22) at 12-week follow-up. The GAIS improved by 0.4 points and was significant compared to baseline (P = 0.0004). Subject satisfaction was high with subjects giving an average satisfaction score of 3.2 (&ldquo;satisfied&rdquo;) out of 4. Pain was rated &ldquo;mild to moderate&rdquo; with an average of 3.9 on a 11-point Wong Baker FACES Scale. Ninety percent (90%) of subjects reported either a mild, moderate, or significant improvement to their treatment area. Eighty percent (80%) of subjects reported that they would recommend the treatment to a friend. There were no reports of adverse events or unanticipated side effects during the duration of the study.

CONCLUSION: A statistically significant reduction in rhytids of the upper lip and the perioral area, was found, as evaluated by independent blinded evaluators. There were no adverse events. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results at last follow-up. J Drugs Dermatol. 2022;21(1):43-48. doi:10.36849/JDD.6492.

PMID:35005858 | DOI:10.36849/JDD.2022.6492

J Cardiovasc Surg (Torino). 2022 Jan 10. doi: 10.23736/S0021-9509.22.11980-4. Online ahead of print.

ABSTRACT

BACKGROUND: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is designed to treat iliac aneurysms with preservation of blood flow through the internal iliac artery (IIA). Little is known about the influence of IBE placement on the IIA geometry. This study aimed to provide detailed insights in the dynamic behavior and geometry of the common iliac artery (CIA) and IIA trajectory and how these are influenced after treatment with an IBE.

METHODS: Pre- and postoperative electrocardiogram-gated computed tomography angiography (ECG-gated CTA) scans were acquired in a prospective study design and analyzed with in-house written algorithms designed for aorto-iliac and endoprosthesis deformation evaluation. Cardiac pulsatility-induced motion patterns and pathlengths were computed by tracking pre-defined locations on the aorto-iliac tract. Centerlines through the CIA-IIA trajectory were used to investigate the static and dynamic geometry, including curvature, torsion, length and tortuosity index (TI).

RESULTS: Fourteen CIA-IIA trajectories were analyzed before and after IBE placement. Cardiac pulsatility-induced motion and pathlengths increased after IBE placement, especially at mid IIA and the first IIA bifurcation (P≤0.04). After IBE placement, static and dynamic curvature, length and TI decreased significantly (P<0.05). Furthermore, the average dynamic torsion increased significantly (P=0.030). The remaining geometrical outcomes were not statistically significant.

CONCLUSIONS: The placement of an IBE device stiffens and straightens the CIA-IIA trajectory. Its relation with clinical outcome is yet to be investigated, which can be done thoroughly with the ECG-gated CTA algorithms used in this study.

PMID:35005875 | DOI:10.23736/S0021-9509.22.11980-4

J Cosmet Dermatol. 2022 Jan 10. doi: 10.1111/jocd.14727. Online ahead of print.

ABSTRACT

OBJECTIVE: To the best of our knowledge, there is currently no such study in the area of extensive calcified costal cartilage rhinoplasty. The study evaluated patients’ satisfaction with extensive calcified costal cartilage compared with no calcified costal cartilage.

METHOD: Thirty-five patients with extensive calcified costal cartilage underwent rhinoplasty at our institution between January 2018 and May 2020. We also used a control group of 35 patients with absent rib cartilage calcification to compare the outcomes. Satisfaction was evaluated by the photogrammetric measurements and Rhinoplasty Outcomes Evaluation (ROE) scale.

RESULTS: We found no significant difference in the nose measurement between the two groups before and after the operation. Besides, both groups had a significant difference in comparison with preoperative after surgery except for the nasofrontal angle. The difference between preoperative and postoperative ROE scores was statistically significant in both groups. We also compared the satisfaction of preoperative and postoperative outcomes between the two groups, where no difference was found between them. Each group had a patient who occurred an infection after surgery.

CONCLUSION: Autologous costal cartilage provides the most abundant source for graft fabrication. Patients with extensive calcified cartilage could undergo rhinoplasty and have satisfactory results instead of choosing an artificial implant.

PMID:35005832 | DOI:10.1111/jocd.14727

Microsc Res Tech. 2022 Jan 10. doi: 10.1002/jemt.24058. Online ahead of print.

ABSTRACT

In vitro models are very useful in dentistry, especially to evaluate preventive methods against dental caries. Although they have been used for more than 30 years, specific demineralization models have not been established for primary enamel, which is more prone to demineralization than permanent enamel. This study evaluates porosity changes in primary enamel surface after a demineralization model through a scientifically validated analytical tool. Nine healthy human anterior primary teeth extracted for therapeutic reasons were included in this study, previous informed consent. The samples were randomly assigned to three groups n = 3: G1_2D, G2_4D, and G3_7D. Scanning electron microscopy (SEM) images at ×200 and ×1000 were taken during two stages: before demineralization (BD) and after demineralization (AD). Morphological characterization was observed at ×1000, while porosity (pore count and perimeter) was analyzed by the ImageJ program, using ×200 SEM images previously converted. Several statistical analyses were used to determine differences (p ≤ .05). Morphological characterization AD revealed new pits and cracks on the enamel surface in G1_2D and G2_4D groups. Localized eroded enamel areas were observed in G3_7D. Pore count of enamel surface BD ranged from 64.26 ± 37.62 to 97.93 ± 34.25 and AD ranged from 150.06 ± 64.86 to 256 ± 58.14. AD, G_4D exhibited a decrease in pore perimeter contrary to G_2D and G_7D. Significant differences were observed. Finally, morphological changes were more evident as days of demineralization increased; 7 days of immersion could be employed as an enamel erosive model. The pore count increased after the demineralization model, BD pores perimeter was heterogeneous, and AD varied according to the immersion period.

PMID:35005814 | DOI:10.1002/jemt.24058

J Cosmet Dermatol. 2022 Jan 10. doi: 10.1111/jocd.14691. Online ahead of print.

ABSTRACT

BACKGROUND: Updates of treatment methods of stable vitiligo are needed to give better outcomes with a shorter duration of treatment.

OBJECTIVE: To test the effect of transdermal 5-fluorouracil (5-FU) delivery using fractional CO₂ (FrCO₂ ) laser versus intralesional 5-FU injection, with narrow-band type ultraviolet B (UVB) (NB-UVB) therapy after both, in the treatment of stable vitiligo.

PATIENTS AND METHODS: The present study comprised 40 patients with nearly symmetrical stable vitiligo lesions. The left side was treated with FrCO₂ laser followed by topical 5-FU (FrCO₂ + 5-FU), while the right side was treated with 5-FU intradermal injection. Both procedures were done at 2-week intervals for 3 sessions followed by 24 sessions of narrow-band UVB for both sides.

RESULTS: Repigmentation was demonstrated on the left side of 90% of patients and the right side of 85% of patients. As much as >50% improvement was demonstrated on the left side of 50% of patients, and the right side of 55% of patients. Intralesional 5-FU showed a statistically significant difference in repigmentation compared to FrCO₂ + 5-FU.

CONCLUSION: Both 5-FU injection and FrCO₂ + 5-FU were effective therapeutic modalities for vitiligo. Patients were more compliant with FrCO₂ + 5-FU.

PMID:35005831 | DOI:10.1111/jocd.14691

J Magn Reson Imaging. 2022 Jan 10. doi: 10.1002/jmri.28053. Online ahead of print.

ABSTRACT

BACKGROUND: Magnetic resonance feature tracking (MR-FT) is an imaging technique that quantifies both global and regional myocardial strain. Currently, conventional MR-FT provides a superior signal and contrast-to-noise ratio but has a relatively low temporal resolution. A higher temporal resolution MR-FT technique may provide improved results.

PURPOSE: To explore the impact of higher temporal resolution on left ventricular (LV) myocardial strain measurements using MR-FT.

STUDY TYPE: Prospective.

POPULATION: One hundred and fifty-three participants including five healthy subjects and patients with various cardiac diseases referred to MR for cardiac assessment.

FIELD STRENGTH: 3 T, balanced steady-state free precession sequence with and without compressed sensing (temporal resolution: 10 msec and 40 msec, respectively).

ASSESSMENT: Conventional (40 msec) and higher (10 msec) temporal resolution data were acquired in all subjects during the same scanning session. Global circumferential strain (GCS), global longitudinal strain (GLS), and global radial strain (GRS) as well as peak systolic and diastolic strain rates (SRs) were measured by MR-FT and compared between the two temporal resolutions. We also performed subgroup analyses according to heart rates (HRs) and LV ejection fraction (LVEF).

STATISTICAL TESTS: Paired t-test, Wilcoxon signed-rank test, linear regression analyses, Bland-Altman plots. A P value <0.05 was considered to be statistically significant.

RESULTS: GCS and GRS were significantly higher in the 10-msec temporal resolution studies compared to the 40-msec temporal resolution studies (GCS: -13.00 ± 6.58% vs. -12.51 ± 5.76%; GRS: 21.97 ± 14.54% vs. 20.62 ± 12.52%). In the subgroup analyses, significantly higher GLS, GCS, and GRS values were obtained in subjects with LVEF ≥50%, and significantly higher GCS and GRS values were obtained in subjects with HRs <70 bpm when assessed with the 10-msec vs. the 40-msec temporal resolutions. All the peak systolic and diastolic SRs were significantly higher in the higher temporal resolution acquisitions. This was also true for all subgroups.

DATA CONCLUSIONS: Higher temporal resolution resulted in significantly higher cardiac strain and SR values using MR-FT and could be beneficial, particularly in patients with LVEF ≥50% and HR <70 bpm.

LEVEL OF EVIDENCE: 1 TECHNICAL EFFICACY: Stage 1.

PMID:35005810 | DOI:10.1002/jmri.28053

J Magn Reson Imaging. 2022 Jan 10. doi: 10.1002/jmri.28059. Online ahead of print.

ABSTRACT

BACKGROUND: Gadoxetic acid-enhanced magnetic resonance imaging (MRI) is useful in detecting liver metastases from pancreatic ductal adenocarcinoma (PDAC). However, the long examination time limits its utility in the initial workup of patients with PDAC.

PURPOSE: To evaluate the incremental value of an abbreviated gadoxetic acid-enhanced MRI for the detection of liver metastases in patients with PDAC.

STUDY TYPE: Retrospective.

POPULATION: Patients (N = 130) with potentially resectable PDAC (women, 58 [44.6%]).

FIELD STRENGTH/SEQUENCE: 1.5 T and 3 T; gradient dual-echo T1-weighted (in-phase and opposed-phase), fat-suppressed fast spin-echo T2-weighted, single-shot echo-planar diffusion-weighted, and three-dimensional fat-suppressed T1-weighted gradient-echo dynamic contrast-enhanced and hepatobiliary phase sequences, as well as contrast-enhanced computed tomography (CECT).

ASSESSMENT: Three radiologists independently reviewed three different image sets to detect liver metastases: set 1, CECT alone; set 2, CECT and abbreviated MRI comprising fat-suppressed T2-weighted, diffusion-weighted, and hepatobiliary phase images; and set 3, CECT and standard gadoxetic acid-enhanced MRI.

STATISTICAL TESTS: Figure of merit (FOM) was compared using the jackknife alternative free-response receiver operating characteristics, and other per-lesion and per-patient diagnostic parameters for each image set were compared using McNemar’s and Fisher’s test. P < 0.05 was considered statistically significant.

RESULTS: A total of 43 liver metastases were identified in 13 patients. Reader-averaged FOM to detect liver metastases were significantly higher for sets 2 (0.884) and 3 (0.886) than for set 1 (0.609), while they were comparable between sets 2 and 3 (P = 0.96). The mean per-patient sensitivities, negative predictive values, and accuracies were significantly higher for sets 2 and 3 than for set 1, while those between sets 2 and 3 were not significantly different (not applicable, P > 0.99, and P > 0.99, respectively).

DATA CONCLUSION: Gadoxetic acid-enhanced MRI combined with CECT had higher diagnostic performance than CECT alone for the detection of liver metastases in patients with PDAC. The incremental values were comparable for the abbreviated MRI and standard MRI.

LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

PMID:35005813 | DOI:10.1002/jmri.28059

J Ultrasound Med. 2022 Jan 10. doi: 10.1002/jum.15923. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the changes of blood flow in adenomyosis (AM) after higher-dose oxytocin (OT) in different doses, and to evaluate the safety for patients.

METHODS: A total of 124 patients with AM were randomly divided into 4 groups with continuous intravenous infusion of OT as 0.06, 0.12, 0.24 and 0.36 U/min, respectively. The changes of arteries of AM before and after intravenous infusion of OT were observed by color Doppler ultrasound. The changes of blood flow volume of the artery of AM before and after intravenous infusion of OT were compared among the 4 groups, and the vital signs and adverse drug reactions were monitored during intravenous drip.

RESULTS: During the trial, no severe adverse reactions occurred and the vital signs of all the patients were stable. Among the 4 groups, it was found that there was a significant difference in the change of blood flow volume of blood artery in AM lesions between 0.06 U/min OT group and the other three groups after intravenous drip of OT (P < .05), but there was no significant difference in blood flow volume among the three groups (P > .05), and the difference of adverse drug reactions was statistically significant with the increase of OT dose (P < .05).

CONCLUSION: OT can effectively reduce the blood flow volume of AM lesions, and continuous intravenous infusion of 0.12 U/min OT is an appropriate dose that can not only minimize the blood flow volume but also reduce the incidence of adverse drug reactions.

PMID:35005793 | DOI:10.1002/jum.15923

Cochrane Database Syst Rev. 2022 Jan 10;1:CD009151. doi: 10.1002/14651858.CD009151.pub2.

ABSTRACT

BACKGROUND: Recurrent vulvovaginal candidiasis (RVVC) affects up to 5% of women. No comprehensive systematic review of treatments for RVVC has been published.

OBJECTIVES: The primary objective was to assess the effectiveness and safety of pharmacological and non-pharmacological treatments for RVVC. The secondary objective was to assess patient preference of treatment options.

SEARCH METHODS: We conducted electronic searches of bibliographic databases, including CENTRAL, MEDLINE, Embase, and CINAHL (search date 6 October 2021). We also handsearched reference lists of identified trials and contacted authors of identified trials, experts in RVVC, and manufacturers of products for vulvovaginal candidiasis.

SELECTION CRITERIA: We considered all published and unpublished randomised controlled trials evaluating RVVC treatments for at least six months, in women with four or more symptomatic episodes of vulvovaginal candidiasis in the past year. We excluded women with immunosuppressive disorders or taking immunosuppressant medication. We included women with diabetes mellitus and pregnant women. Diagnosis of RVVC must have been confirmed by presence of symptoms and a positive culture and/or microscopy. We included all drug and non-drug therapies and partner treatment, assessing the following primary outcomes: • number of clinical recurrences per participant per year (recurrence defined as clinical signs and positive culture/microscopy); • proportion of participants with at least one clinical recurrence during the treatment and follow-up period; and • adverse events.

DATA COLLECTION AND ANALYSIS: Two authors independently reviewed titles and abstracts to identify eligible trials. Duplicate data extraction was completed independently by two authors. We assessed risk of bias as described in the Cochrane Handbook for Systematic Reviews of Interventions. We used the fixed-effects model for pooling and expressed the results as risk ratio (RR) with 95% confidence intervals (CI). Where important statistical heterogeneity was present we either did not pool data (I² > 70%) or used a random-effects model (I² 40-70%). We used the GRADE tool to assess overall certainty of the evidence for the pooled primary outcomes.

MAIN RESULTS: Studies: Twenty-three studies involving 2212 women aged 17 to 67 years met the inclusion criteria. Most studies excluded pregnant women and women with diabetes or immunosuppression. The predominant species found on culture at study entry was Candida albicans. Overall, the included studies were small (<100 participants). Six studies compared antifungal treatment with placebo (607 participants); four studies compared oral versus topical antifungals (543 participants); one study compared different oral antifungals (45 participants); two studies compared different dosing regimens for antifungals (100 participants); one study compared two different dosing regimens of the same topical agent (23 participants); one study compared short versus longer treatment duration (26 participants); two studies assessed the effect of partner treatment (98 participants); one study compared a complementary treatment (Lactobacillus vaginal tablets and probiotic oral tablets) with placebo (34 participants); three studies compared complementary medicine with antifungals (354 participants); two studies compared ‘dermasilk’ briefs with cotton briefs (130 participants); one study examined Lactobacillus vaccination versus heliotherapy versus ciclopyroxolamine (90 participants); one study compared CAM treatments to an antifungal treatment combined with CAM treatments (68 participants). We did not find any studies comparing different topical antifungals. Nine studies reported industry funding, three were funded by an independent source and eleven did not report their funding source. Risk of bias: Overall, the risk of bias was high or unclear due to insufficient blinding of allocation and participants and poor reporting. Primary outcomes: Meta-analyses comparing drug treatments (oral and topical) with placebo or no treatment showed there may be a clinically relevant reduction in clinical recurrence at 6 months (RR 0.36, 95% CI 0.21 to 0.63; number needed to treat for an additional beneficial outcome (NNTB) = 2; participants = 607; studies = 6; I² = 82%; low-certainty evidence) and 12 months (RR 0.80, 95% CI 0.72 to 0.89; NNTB = 6; participants = 585; studies = 6; I² = 21%; low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. We are very uncertain whether oral drug treatment compared to topical treatment increases the risk of clinical recurrence at 6 months (RR 1.66, 95% CI 0.83 to 3.31; participants = 206; studies = 3; I² = 0%; very low-certainty evidence) and reduces the risk of clinical recurrence at 12 months (RR 0.95, 95% CI 0.71 to 1.27; participants = 206; studies = 3; I² = 10%; very low-certainty evidence). No study reported on the number of clinical recurrences per participant per year. Adverse events were scarce across both treatment and control groups in both comparisons. The reporting of adverse events varied amongst studies, was generally of very low quality and could not be pooled. Overall the adverse event rate was low for both placebo and treatment arms and ranged from less than 5% to no side effects or complications.

AUTHORS’ CONCLUSIONS: In women with RVVC, treatment with oral or topical antifungals may reduce symptomatic clinical recurrences when compared to placebo or no treatment. We were unable to find clear differences between different treatment options (e.g. oral versus topical treatment, different doses and durations). These findings are not applicable to pregnant or immunocompromised women and women with diabetes as the studies did not include or report on them. More research is needed to determine the optimal medication, dose and frequency.

PMID:35005777 | DOI:10.1002/14651858.CD009151.pub2