Joint practice guidelines for radionuclide lymphoscintigraphy for sentinel node localization in oral/oropharyngeal squamous cell carcinoma

Involvement of the cervical lymph nodes is the most important prognostic factor for patients with oral/oropharyngeal squamous cell carcinoma (OSCC), and the decision whether to electively treat patients with clinically negative necks remains a controversial topic. Sentinel node biopsy (SNB) provides a minimally invasive method of determining the disease status of the cervical node basin, without the need for a formal neck dissection. This technique potentially improves the accuracy of histological nodal staging and avoids over-treating three-quarters of this patient population, minimizing associated morbidity. The technique has been validated for patients with OSCC, and larger-scale studies are in progress to determine its exact role in the management of this patient population. This article was designed to outline the current best practice guidelines for the provision of SNB in patients with early-stage OSCC, and to provide a framework for the currently evolving recommendations for its use. These guidelines were prepared by a multidisciplinary surgical/nuclear medicine/pathology expert panel under the joint auspices of the European Association of Nuclear Medicine (EANM) Oncology Committee and the Sentinel European Node Trial Committee

The International Consultation on Incontinence Questionnaires (ICIQ): An update on status and direction

Aims: In its 22nd year, the International Consultation on Incontinence Questionnaire (ICIQ) project continues to promote its primary objective; the development and dissemination of patient completed questionnaires for the standardized, high-quality assessment of urinary, bowel, and vaginal symptoms. The paper gives an update on the ICIQ in the context of current scientific developments of PROM design and regulatory requirements, and plans are outlined for its future direction. Methods: An online library of all questionnaires, including over 300 translations has been launched to facilitate access through a semi-automated registration system. The ICIQ project continues to update its protocol to meet current scientific standards and incorporate methodological advances within PROM development. Results: Nineteen psychometrically validated patient-reported outcome measures (PROMs) are published for use in clinical practice and research, including amongst others, a bladder diary, male and female lower urinary tract symptoms, long term catheter, pad use, and bowel symptom questionnaires. The original ICIQ-UI Short Form for the assessment of urinary incontinence continues to be the most internationally used questionnaire and has been translated into over 60 languages. New questionnaires which are under development include the ICIQ-Underactive Bladder and ICIQ-Satisfaction. We anticipate the new website and online library will further facilitate the ease of dissemination and availability of the questionnaires for clinical practice and research. Conclusion: The ICIQ continues to successfully achieve its primary objective. Going forward, a greater focus on promoting routine clinical use and the potential for electronic integration into databases and medical records is envisaged

Tuolinjalan jyrsintäkiinnittimien suunnittelu

Opinnäytetyön tavoitteena oli suunnitella robotilla tehtävään kappaleenkäsittelyyn soveltuvat automaattiset jyrsintäkiinnikkeet epäsymmetrisen puusta valmistettavan tuolinjalan jyrsintään. Työ toteutettiin Savon ammatti- ja aikuisopiston puualan tiloihin rakennetussa RFID-tekniikan opetus- ja testausympäristössä. Suunnitteluvaiheessa pyrittiin hyödyntämään olemassa olevien laitteiden ja koneiden, kuten CNC-jyrsimen ja kappaleenkäsittelyrobotin ominaisuuksia jyrsintäkiinnittimien valmistuksessa. Opinnäytetyössä käytiin läpi työkappaleen, jyrsimen ja robotin asettamia vaatimuksia ja niiden huomiointia kiinnittimien suunnittelussa ja pohdittiin RFID-sirun integroinnin mahdollisuuksia työkappaleen työkierron ohjauksessa. Kiinnittimien suunnitteluun käytettiin Autodesk Inventor 3D -suunnitteluohjelmaa, jolla luotiin työn tuloksena syntyneet työkappaleen dimensioiden ja työstövaatimusten perusteella suunnitellut kiinnittimien tietokonemallit. Tietokonemallien pohjalta rakennettiin jyrsintään ja automaattiseen kappaleenvaihtoon soveltuvat jyrsintäkiinnittimet, joiden avulla tuolinjalkojen valmistus onnistuu miehittämättömään tuotantoon soveltuvassa solussa.The objective of this final year project was to design mechanical clamps which would be suitable for being used with a CNC milling machine. The clamps were designed according to the dimensions and design principles of a particular chair leg which is part of the Sakky-chair assembly. The project was commissioned by Savo Vocational Colleges and it is part of the RFID (Radio Frequency Identification) project. The design process was started by researching old manual clamps used for attaching the chair leg blank to the milling table. These manual clamps were used as design examples in the beginning of the process. The clamps were designed using Autodesk Inventor 3D CAD software. The clamps were designed to the testing phase and will be manufactured over the coming months. The new automatically controlled clamps were designed to be operated by using negative pressure that is available through the vacuum cups of the milling machines. Handling the blanks and the milled chair legs was designed to be carried out using the available material handling robot. The implementation of RFID tags for transferring milling and handling information in the blanks will be investigated. In order to get the clamp design to work, some minor tweaks to the final design might be necessary. These necessary design tweaks are mostly due to some small dimensional differences between different chair leg blanks used

International Consultation on Incontinence Questionnaire-Satisfaction: psychometric testing of a new patient-reported outcome measure for the evaluation of satisfaction after urological surgery

Objectives: To evaluate the psychometric properties of a new patient-reported outcome measure (PROM), the International Consultation on Incontinence Questionnaire-Satisfaction (ICIQ-S), to assess satisfaction after urological surgery. Subjects/Patients and Methods: Following item development, the developmental ICIQ-S (dICIQ-S) was used within in a randomised control trial comparing two types of surgery for male prostatic obstruction at 1.5, 3, and 12months after surgery. Reliability was assessed by Cronbach’s α and construct validity by the correlation of scores with concurrently administered PROMs of known validity: ICIQ-Male Lower Urinary Tract Symptoms (LUTS), International Prostate Symptom Score, and the ICIQ-LUTS Quality of Life. Results: A total of 410 men were included in the trial. Missing data was generally low for the dICIQ-S [mean (range) 1.6

Establishing a stable, repeatable platform for measuring changes in sperm DNA methylation

Abstract Background Several independent research groups have shown that alterations in human sperm methylation profiles correlate with decreased fecundity and an increased risk of poor embryo development. Moving these initial findings from the lab into a clinical setting where they can be used to measure male infertility though requires a platform that is stable and robust against batch effects that can occur between sample runs. Operating parameters must be established, performance characteristics determined, and guidelines set to ensure repeatability and accuracy. The standard for technical validation of a lab developed test (LDT) in the USA comes from the Clinical Laboratory Improvement Amendments (CLIA). However, CLIA was introduced in 1988, before the advent of genome-wide profiling and associated computational analysis. This, coupled with its intentionally general nature, makes its interpretation for epigenetic assays non-trivial. Results Here, we present an interpretation of the CLIA technical validation requirements for profiling DNA methylation and calling aberrant methylation using the Illumina Infinium platform (e.g., the 450HM and MethylationEPIC). We describe an experimental design to meet these requirements, the experimental results obtained, and the operating parameters established. Conclusions The CLIA guidelines, although not intended for high-throughput assays, can be interpreted in a way that is consistent with modern epigenetic assays. Based on such an interoperation, Illumina’s Infinium platform is quite amenable to usage in a clinical setting for diagnostic work

The development of the ICIQ-UAB: A patient reported outcome measure for underactive bladder

Aims: To present the development of the International Consultation on Incontinence Questionnaire-underactive bladder (ICIQ-UAB) as the first patient reported outcome measure for the assessment of the symptoms and impact on the health-related quality of life of UAB developed in-line with the Food and Drug Administration Guidance for Industry.Methods: Draft items were developed following 44 semi-structured concept elicitation interviews in the UK and refined using 36 cognitive interviews. A pilot study was designed to assess the draft ICIQ-UAB's initial psychometric properties with 54 patients recruited from European hospitals. Further concept elicitation interviews were also carried out with 11 patients in the US and 10 patients in Japan. All participants had a prior urodynamic diagnosis of detrusor underactivity.Results: The cognitive interviews confirmed the initial items to be understood and interpreted as intended. Pilot testing showed that both internal consistency (Cronbach's α ≥ 0.85) and test-retest reliability (stable patients; intraclass correlation coefficient ≥ 0.88) werehigh. The interviews in the US and Japan elicited symptoms and impacts that support previous findings in the UK and provided further insight into the experiences of patients in those countries. The developmental ICIQ-UAB was refined using the evidence from all substudies.Conclusions: The validity and reliability of the ICIQ-UAB were supported in a pilot study settingand the wider cultural applicability by the additional interviews in the US and Japan. Following further validation in future clinical trials, the developmental ICIQ-UAB is envisaged as an important tool for the monitoring of future UAB treatment strategies

Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial:study protocol for randomized controlled trial

<p>Background: Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic.</p> <p>Methods/design: The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014.</p> <p>Discussion: This is the first study to look at the implementation of computed tomography in the patient care pathway that is outcome focused. This study will have major implications for the management of patients with cardiovascular disease.</p&gt