Validation of the electronic version of the international index of erectile function (IIEF-5 and IIEF-15): A crossover study

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application. OBJECTIVE: The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15. METHODS: This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient. RESULTS: A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively. CONCLUSIONS: We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version. TRIAL REGISTRATION: ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388

Contrast-Enhanced Ultrasound (CEUS)

Contrast-enhanced ultrasound (CEUS) imaging is a widely used medical imaging technique combining ultrasound and ultrasound contrast agents (UCAs) for clinical decision-making. UCAs are gas microbubbles coated with a biocompatible shell; they stay intravascular and act as resonant scatterers producing echoes with characteristic harmonics that can be used for real-time evaluation of the vascular architecture and contrast enhancement patterns in regions of interest. In urology, CEUS has generally been used for the diagnosis of prostate cancer (PCa) through improved targeting for prostate biopsy and evaluation of small renal masses, especially when contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) is contraindicated. Current clinical applications of CEUS have expanded to include interventional and postinterventional treatment evaluation and monitoring of focal therapy for benign and malignant urological conditions. CEUS can provide early and convincing evidence on the local effect and extent of the ablated zone and possibly also the identification of residual tumor. Recognizing the important evolving role of CEUS in the assessment of various urological conditions, greater level of standardization and consistency is needed to facilitate high-quality integration in daily clinical practice. Further investigation and refinement will be necessary to define the clinical role of CEUS as stand-alone tool, or in a multiparametric fashion with other emerging ultrasound modalities such as sonoelastography or micro-ultrasound.</p

Needle-based optical coherence tomography for the detection of prostate cancer: a visual and quantitative analysis in 20 patients

Contains fulltext : 198327.pdf (publisher's version ) (Open Access

Contrast-Enhanced Ultrasound (CEUS)

Contrast-enhanced ultrasound (CEUS) imaging is a widely used medical imaging technique combining ultrasound and ultrasound contrast agents (UCAs) for clinical decision-making. UCAs are gas microbubbles coated with a biocompatible shell; they stay intravascular and act as resonant scatterers producing echoes with characteristic harmonics that can be used for real-time evaluation of the vascular architecture and contrast enhancement patterns in regions of interest. In urology, CEUS has generally been used for the diagnosis of prostate cancer (PCa) through improved targeting for prostate biopsy and evaluation of small renal masses, especially when contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) is contraindicated. Current clinical applications of CEUS have expanded to include interventional and postinterventional treatment evaluation and monitoring of focal therapy for benign and malignant urological conditions. CEUS can provide early and convincing evidence on the local effect and extent of the ablated zone and possibly also the identification of residual tumor. Recognizing the important evolving role of CEUS in the assessment of various urological conditions, greater level of standardization and consistency is needed to facilitate high-quality integration in daily clinical practice. Further investigation and refinement will be necessary to define the clinical role of CEUS as stand-alone tool, or in a multiparametric fashion with other emerging ultrasound modalities such as sonoelastography or micro-ultrasound

One-to-one registration of en-face optical coherence tomography attenuation coefficients with histology of a prostatectomy specimen

Optical coherence tomography (OCT), enables high-resolution 3D imaging of the morphology of light scattering tissues. From the OCT signal, parameters can be extracted and related to tissue structures. One of the quantitative parameters is the attenuation coefficient; the rate at which the intensity of detected light decays in depth. To couple the quantitative parameters with the histology one-to-one registration is needed. The primary aim of this study is to validate a registration method of quantitative OCT parameters to histological tissue outcome through one-to-one registration of OCT with histology. We matched OCT images of unstained fixated prostate tissue slices with corresponding histology slides, wherein different histologic types were demarcated. Attenuation coefficients were determined by a supervised automated exponential fit (corrected for point spread function and sensitivity roll-off related signal losses) over a depth of 0.32 mm starting from 0.10 mm below the automatically detected tissue edge. Finally, the attenuation coefficients corresponding to the different tissue types of the prostate were compared. From the attenuation coefficients, we produced the squared relative residue and goodness-of-fit metric R2 . This article explains the method to perform supervised automated quantitative analysis of OCT data, and the one-to-one registration of OCT extracted quantitative data with histopathological outcomes

Reliable Visualization of the Treatment Effect of Transperineal Focal Laser Ablation in Prostate Cancer Patients by Magnetic Resonance Imaging and Contrast-enhanced Ultrasound Imaging

Background: Transperineal focal laser ablation (TPLA) treatment for prostate cancer (PCa) is an experimental focal ablative therapy modality with low morbidity. However, a dosimetry model for TPLA is lacking. Objective: To determine (1) the three-dimensional (3D) histologically defined ablation zone of single- and multifiber TPLA treatment for PCa correlated with magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) and (2) a reliable imaging modality of ablation zone volumetry. Design, setting, and participants: This was a prospective, multicenter, and interventional phase I/II pilot study with an ablate-and-resect design. TPLA was performed in 12 patients with localized prostate cancer divided over four treatment regimens to evaluate potential variation in outcomes. Intervention: TPLA was performed approximately 4 wk prior to robot-assisted radical prostatectomy (RARP) in a daycare setting using local anesthesia. Outcome measurements and statistical analysis: Four weeks after TPLA, ablation zone volumetry was determined on prostate MRI and CEUS by delineation and segmentation into 3D models and correlated with whole-mount RARP histology using the Pearson correlation index. Results and limitations: Twelve office-based TPLA procedures were performed successfully under continuous transrectal ultrasound guidance using local perineal anesthesia. No serious adverse events occurred. A qualitative analysis showed a clear demarcation of the ablation zone on T2-weighted MRI, dynamic contrast-enhanced MRI, and CEUS. On pathological evaluation, no remnant cancer was observed within the ablation zone. Ablation zone volumetry on CEUS and T2-weighted MRI compared with histology had a Pearson correlation index of r = 0.94 (95% confidence interval [CI] 0.74–0.99, p < 0.001) and r = 0.93 (95% CI 0.73–0.98, p < 0.001), respectively. Conclusions: CEUS and prostate MRI could reliably visualize TPLA ablative effects after minimally invasive PCa treatment with a high concordance with histopathological findings and showed no remnant cancer. Patient summary: The treatment effects of a novel minimally invasive ablation therapy device can reliably be visualized with radiological examinations. These results will improve planning and performance of future procedures