B-AB21-05 ADDED VALUE OF VEIN OF MARSHAL ETHANOLISATION FOR MITRAL ISTHMUS LINE ABLATION. A RANDOMIZED STUDY

Abstract Background Correct preoperative estimation of the malignant extent is crucial for optimal planning of breast cancer surgery. The sensitivity of mammography is lower in dense breasts, and additional imaging techniques are sometimes warranted. Contrast-enhanced mammography (CEM) has shown similar sensitivity and in some cases better specificity, than magnetic resonance imaging (MRI) in small, observational studies. CEM may be more cost-effective than MRI, and may provide better identification of the tumor extent, however, no randomized trials have been performed to date to investigate the added value of CEM. In a feasibility study, we found that the treatment was changed in 10/47 (21%) cases after additional CEM. The purpose of the present study is to evaluate the added value of CEM in preoperative staging of breast cancer in a randomized study. Method This prospective randomized study will include 440 patients with strongly suspected or established diagnosis of breast malignancy, based on assessment with mammography, ultrasound and core biopsy/cytology, and for whom primary surgery is planned. Patients will be randomized 1:1 using a web-based randomization tool to additional investigation with CEM or no further imaging. The CEM findings will be taken into consideration, which may lead to changes in primary treatment, which is the primary endpoint of this study. Secondary endpoints include rate of reoperation and number of avoidable mastectomies, as well as a cost-benefit analysis of additional CEM. Patient-reported health-related quality of life will be investigated at 1 year with the validated Breast-Q™ questionnaire. The rate of local recurrence or new cancer ipsi- or contralaterally within 5 years will be assessed from medical records and pathology reports. Discussion The aim of this trial is to explore the added value of CEM in preoperative staging of breast cancer. The results obtained from this study will contribute to our knowledge on CEM as an additional imaging method to standard investigation with digital mammography and ultrasound. The findings may also provide additional information on which patient groups would benefit from CEM, and on the economic aspects of CEM in standard preoperative practice. Trial registration This trial is registered at clinicaltrials.gov, registration no: NCT04437602, date of registration: June 18, 2020.

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Does Multiparametric Magnetic Resonance of Prostate Outperform Risk Calculators in Predicting Prostate Cancer in Biopsy Naïve Patients?

Frontiers in Oncology ◽

10.3389/fonc.2020.603384 ◽

2021 ◽

Vol 10 ◽

Author(s):

Ugo Giovanni Falagario ◽

Giovanni Silecchia ◽

Salvatore Mariano Bruno ◽

Michele Di Nauta ◽

Mario Auciello ◽

...

Keyword(s):

Prostate Cancer ◽

Randomized Study ◽

Multivariable Analysis ◽

Added Value ◽

Collaborative Group ◽

The Novel ◽

Net Benefit ◽

Decision Curve Analysis ◽

Clinically Significant ◽

Asymptomatic Men

BackgroundEuropean Association of Urology (EAU) guidelines recommend using risk-calculators (RCs), imaging or additional biomarkers in asymptomatic men at risk of prostate cancer (PCa).ObjectivesTo compare the performance of mpMRI, a RC we recently developed and two commonly used RC not including mpMRI in predicting the risk of PCa, as well as the added value of mpMRI to each RC.Design, Setting, and ParticipantsSingle-center retrospective study evaluating 221 biopsy-naïve patients who underwent prebiopsy mpMRI.Outcome Measurements and Statistical AnalysisPatients’ probabilities of any PCa and clinically significant PCa (csPC, defined as Gleason-Score ≥3 + 4) were computed according to mpMRI, European Randomized Study of Screening for Prostate Cancer RC (ERSPC-RC), the Prostate Biopsy Collaborative Group RC (PBCG-RC) and the Foggia Prostate Cancer RC (FPC-RC). Logistic regression, AUC, and Decision curve analysis (DCA) were used to assess the accuracy of tested models.Results and LimitationThe FPC-RC outperformed mpMRI in diagnosing both any PCa (AUC 0.76 vs 0.69) and csPCa (AUC 0.80 vs 0.75). Conversely mpMRI showed a higher accuracy in predicting any PCa compared to the PBCG-RC and the ERSPC-RC but similar performances in predicting csPCa. At multivariable analysis predicting csPCa and any PCa, the addition of mpMRI findings improved the accuracy of each calculator. DCA showed that the FPC-RC provided a greater net benefit than mpMRI and the other RCs. The addition of mpMRI findings improved the net benefit provided by each calculator.ConclusionsmpMRI was outperformed by the novel FPC-RC and showed similar performances compared to the PBCG and ERSPC RCs in predicting csPCa. The addition of mpMRI findings improved the diagnostic accuracy of each of these calculators

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PP185 Clinical Papers: Which Are Ongoing Studies To Assess MHealth In 2020?

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319002733 ◽

2019 ◽

Vol 35 (S1) ◽

pp. 71-72

Author(s):

Cyril Olivier ◽

Estelle Piotto ◽

Corinne Collignon ◽

Hubert Galmiche ◽

Chantal Bélorgey

Keyword(s):

Mobile Health ◽

Medical Devices ◽

Clinical Studies ◽

Randomized Study ◽

Clinical Development ◽

Added Value ◽

Mobile Health Systems ◽

Major Criterion ◽

Study Designs ◽

Patient Use

IntroductionMobile health systems (MHS) are one of the more spreading technologies in the field of medicine. However, identification of useful MHS is rather challenging. Few of them are, or could be, connected medical devices (cMD). Like other medical devices, cMD must be assessed to validate claimed benefits for reimbursement purposes. Clinical added value demonstration is a major criterion used to satisfy administrative requirements. With the increase of clinical studies that are including MHS, study registries can be used for insight into the type of evidence expected to become available in the near future.MethodsIn 2018, the French National Authority for Health (HAS) performed a review of registered MHS clinical study designs. The Clinicaltrials.gov database was consulted for all studies indexed with the terms “mHealth” and “mobile health” for the search fields “study title”, “conditions” and “interventions”.ResultsFour hundred and fifteen clinical studies were registered. Three hundred and eighty studies were interventional with most comprised of a randomized study design (75 percent). Fifteen had a crossover design. Only few observational studies (n = 35) were registered. These mainly concerned (59 percent) patient use of an app on a smartphone without any other device.ConclusionsPatterns of clinical studies were not found to significantly differ between MHS and other medical devices. Most of the clinical studies were randomized and specific criteria to assess MHS could easily be identified. However, specific methodologies for clinical development are not used in practice for cMD health technology assessment. In the absence of validated and specific methodology for clinical development, current methods that are being used in these ongoing studies will nonetheless be generating evidence for the upcoming years.

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Left Mitral Isthmus Ablation Associated With PV Isolation: Long-term Results of a Prospective Randomized Study

Yearbook of Cardiology ◽

10.1016/s0145-4145(07)70258-7 ◽

2006 ◽

Vol 2006 ◽

pp. 432

Author(s):

A.L. Waldo

Keyword(s):

Randomized Study ◽

Long Term Results ◽

Prospective Randomized Study ◽

Mitral Isthmus

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The added value of video for consultations in telemedicine for minor injuries work

Journal of Telemedicine and Telecare ◽

10.1258/jtt.2011.110318 ◽

2011 ◽

Vol 17 (8) ◽

pp. 427-431 ◽

Cited By ~ 6

Author(s):

Fiona Mair ◽

Christine McClusky ◽

Tom Wilsgaard ◽

Richard Wootton

Keyword(s):

Randomized Study ◽

Added Value ◽

X Ray ◽

Communications Systems ◽

Local Decision ◽

Video Link ◽

Local Decision Making ◽

Minor Injuries ◽

Cost Implications ◽

The Cost

We examined the decisions made about transfer of patients with minor injuries, when telemedicine support was provided to the remote nurses in two different ways: the telemedicine doctor either used a video link, or a telephone call with viewing of digital X-ray images (a low resolution version of Picture Archiving and Communications Systems [PACS]). A quasi-randomized study design was used, with a panel of 20 emergency medicine doctors who independently reviewed previously-stored consultations using the two modalities. In total, 60 case reviews were conducted during five sessions, representing 33 different cases from the routine workload of Minor Treatment Centres in Scotland. More experienced doctors transferred fewer patients than less experienced doctors. The proportion of patients transferred was higher when PACS was used than when video was used in most of the cases. A mixed effects logistic regression model was fitted to the data. The estimated odds for patient transfer were 56% lower when video was used instead of PACS (odds ratio 0.44, 95% confidence interval 0.20, 0.93). Although the cost implications are not yet known, video support for local decision-making should remain the preferred method of telemedicine for minor injuries work.

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Performance of Indoor Residual Spray on entomological parameters of malaria transmission using pirimiphos-methyl in the context of pyrethroids resistance in Koulikoro region, Mali.

10.21203/rs.2.21391/v1 ◽

2020 ◽

Author(s):

Moussa KEITA ◽

Nafomon SOGOBA ◽

Boïssé Traoré ◽

Fousseyni Kané ◽

Boubacar Coulibaly ◽

...

Keyword(s):

Malaria Transmission ◽

Indoor Residual Spray ◽

Control Strategy ◽

Randomized Study ◽

Added Value ◽

Bioassay Test ◽

Pirimiphos Methyl ◽

Long Lasting Insecticidal Nets ◽

Malaria Control Strategy ◽

Entry Window

Abstract Background: Following vectors resistance to both pyrethroid and carbamates, organophosphate (pirimiphos-methyl) was used in the Indoor Residual Spray campaigns of 2015 to 2016 in the district of Koulikoro. In this context, we assessed the effect of IRS on malaria transmission by comparing entomological indices in two localities: Koulikoro (LLINs+IRS), and Banamba (LLINs -only) districts. Methods: The study was conducted in two villages of each of Koulikoro and Banamba in 2016. Pyrethroid spray catch and entry window trapping where used to collect mosquitoes monthly WHO bioassay test was used to assess mosquito’s susceptibility to insecticides. Mosquitoes were identified into species by PCR and the infection rate using ELISA. Results: An. coluzii was by far the most frequent species. Its density was rainfall dependent in no-IRS area, and almost independent in IRS area. The IR in the no-IRS area was 1.24%, while in the IRS area, we could not detect infection. In the no-IRS area, the EIR was 0.21 infective bites /person month with the peak in September. High resistance to pyrethroids and carbamates and susceptibility to organophosphates was observed in all sites. Conclusion: A big randomized study is needed to better estimate the added value of the IRS in an integrated malaria control strategy. Key words: Mali, IRS, Long-lasting insecticidal nets, insecticide resistance, transmission.

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The Added Value of Graphical Input and Display for Electron Lens Design

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100179701 ◽

1990 ◽

Vol 48 (1) ◽

pp. 190-191

Author(s):

B. Lencova ◽

G. Wisselink

Keyword(s):

Flux Density ◽

Numerical Data ◽

Added Value ◽

Lens Design ◽

Step Size ◽

Magnetic Lens ◽

Flux Lines ◽

Fine Mesh ◽

Electron Lens ◽

User Friendly

Recent progress in computer technology enables the calculation of lens fields and focal properties on commonly available computers such as IBM ATs. If we add to this the use of graphics, we greatly increase the applicability of design programs for electron lenses. Most programs for field computation are based on the finite element method (FEM). They are written in Fortran 77, so that they are easily transferred from PCs to larger machines.The design process has recently been made significantly more user friendly by adding input programs written in Turbo Pascal, which allows a flexible implementation of computer graphics. The input programs have not only menu driven input and modification of numerical data, but also graphics editing of the data. The input programs create files which are subsequently read by the Fortran programs. From the main menu of our magnetic lens design program, further options are chosen by using function keys or numbers. Some options (lens initialization and setting, fine mesh, current densities, etc.) open other menus where computation parameters can be set or numerical data can be entered with the help of a simple line editor. The "draw lens" option enables graphical editing of the mesh - see fig. I. The geometry of the electron lens is specified in terms of coordinates and indices of a coarse quadrilateral mesh. In this mesh, the fine mesh with smoothly changing step size is calculated by an automeshing procedure. The options shown in fig. 1 allow modification of the number of coarse mesh lines, change of coordinates of mesh points or lines, and specification of lens parts. Interactive and graphical modification of the fine mesh can be called from the fine mesh menu. Finally, the lens computation can be called. Our FEM program allows up to 8000 mesh points on an AT computer. Another menu allows the display of computed results stored in output files and graphical display of axial flux density, flux density in magnetic parts, and the flux lines in magnetic lenses - see fig. 2. A series of several lens excitations with user specified or default magnetization curves can be calculated and displayed in one session.

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Preliminary Findings on the Use of Session Questionnaires to Improve Clinician-Client Alliance With Special Consideration to Clinical Education

Perspectives on Administration and Supervision ◽

10.1044/aas25.1.50 ◽

2015 ◽

Vol 25 (1) ◽

pp. 50-60

Author(s):

Anu Subramanian

Keyword(s):

Graduate Students ◽

Clinical Education ◽

Clinical Decision Making ◽

Rating Scale ◽

Treatment Effectiveness ◽

Clinical Decision ◽

Added Value ◽

Therapeutic Outcomes ◽

Specific Feedback ◽

Stakeholder Perspective

ASHA's focus on evidence-based practice (EBP) includes the family/stakeholder perspective as an important tenet in clinical decision making. The common factors model for treatment effectiveness postulates that clinician-client alliance positively impacts therapeutic outcomes and may be the most important factor for success. One strategy to improve alliance between a client and clinician is the use of outcome questionnaires. In the current study, eight parents of toddlers who attended therapy sessions at a university clinic responded to a session outcome questionnaire that included both rating scale and descriptive questions. Six graduate students completed a survey that included a question about the utility of the questionnaire. Results indicated that the descriptive questions added value and information compared to using only the rating scale. The students were varied in their responses regarding the effectiveness of the questionnaire to increase their comfort with parents. Information gathered from the questionnaire allowed for specific feedback to graduate students to change behaviors and created opportunities for general discussions regarding effective therapy techniques. In addition, the responses generated conversations between the client and clinician focused on clients' concerns. Involving the stakeholder in identifying both effective and ineffective aspects of therapy has advantages for clinical practice and education.

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