A Unified Checklist for Observational and Experimental Research in Software Engineering (Version 1)

Current checklists for empirical software engineering cover either experimental research or case study research but ignore the many commonalities that exist across all kinds of empirical research. Identifying these commonalities, and explaining why they exist, would enhance our understanding of empirical research in general and of the differences between experimental and case study research in particular. In this report we design a unified checklist for empirical research, and identify commonalities and differences between experimental and case study research. We design the unified checklist as a specialization of the general engineering cycle, which itself is a special case of the rational choice cycle. We then compare the resulting empirical research cycle with two checklists for experimental research, and with one checklist for case study research. The resulting checklist identifies important questions to be answered in experimental and case study research design and reports. The checklist provides insights in two different types of empirical research design and their relationships. Its limitations are that it ignores other research methods such as meta-research or surveys. It has been tested so far only in our own research designs and in teaching empirical methods. Future work includes expanding the comparison with other methods and application in more cases, by others than ourselves

Design, validation and dissemination of an undergraduate assessment tool using SimMan® in simulated medical emergencies

Background: Increasingly, medical students are being taught acute medicine using whole-body simulator manikins. Aim: We aimed to design, validate and make widely available two simple assessment tools to be used with Laerdal SimMan (R) for final year students. Methods: We designed two scenarios with criterion-based checklists focused on assessment and management of two medical emergencies. Members of faculty critiqued the assessments for face validity and checklists revised. We assessed three groups of different experience levels: Foundation Year 2 doctors, third and final year medical students. Differences between groups were analysed, and internal consistency and interrater reliability calculated. A generalisability analysis was conducted using scenario and rater as facets in design. Results: A maximum of two items were removed from either checklist following the initial survey. Significantly different scores for three groups of experience for both scenarios were reported (p0.90). Internal consistency was poor (alpha<50.5). Generalizability study results suggest that four cases would provide reliable discrimination between final year students. Conclusions: These assessments proved easy to administer and we have gone some way to demonstrating construct validity and reliability. We have made the material available on a simulator website to enable others to reproduce these assessments

Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device

Validación clínica; Salud digital; Salud participativaValidació clínica; Salut digital; Salut participativaClinical validation; Digital health; Participatory healthThere is increasing interest in the development and deployment of digital solutions to improve patient care and facilitate monitoring in medical practice, e.g., by remote observation of disease symptoms in the patients’ home environment. Digital health solutions today range from non-regulated wellness applications and research-grade exploratory instruments to regulated software as a medical device (SaMD). This paper discusses the considerations and complexities in developing innovative, effective, and validated SaMD for multiple sclerosis (MS). The development of SaMD requires a formalised approach (design control), inclusive of technical verification and analytical validation to ensure reliability. SaMD must be clinically evaluated, characterised for benefit and risk, and must conform to regulatory requirements associated with device classification. Cybersecurity and data privacy are also critical. Careful consideration of patient and provider needs throughout the design and testing process help developers overcome challenges of adoption in medical practice. Here, we explore the development pathway for SaMD in MS, leveraging experiences from the development of Floodlight™ MS, a continually evolving bundled solution of SaMD for remote functional assessment of MS. The development process will be charted while reflecting on common challenges in the digital space, with a view to providing insights for future developers.The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: F. Hoffmann-La Roche Ltd., Basel, Switzerland provided financial support for the publication of this manuscript

Optical techniques for 3D surface reconstruction in computer-assisted laparoscopic surgery

One of the main challenges for computer-assisted surgery (CAS) is to determine the intra-opera- tive morphology and motion of soft-tissues. This information is prerequisite to the registration of multi-modal patient-specific data for enhancing the surgeon’s navigation capabilites by observ- ing beyond exposed tissue surfaces and for providing intelligent control of robotic-assisted in- struments. In minimally invasive surgery (MIS), optical techniques are an increasingly attractive approach for in vivo 3D reconstruction of the soft-tissue surface geometry. This paper reviews the state-of-the-art methods for optical intra-operative 3D reconstruction in laparoscopic surgery and discusses the technical challenges and future perspectives towards clinical translation. With the recent paradigm shift of surgical practice towards MIS and new developments in 3D opti- cal imaging, this is a timely discussion about technologies that could facilitate complex CAS procedures in dynamic and deformable anatomical regions

Medical image computing and computer-aided medical interventions applied to soft tissues. Work in progress in urology

Until recently, Computer-Aided Medical Interventions (CAMI) and Medical Robotics have focused on rigid and non deformable anatomical structures. Nowadays, special attention is paid to soft tissues, raising complex issues due to their mobility and deformation. Mini-invasive digestive surgery was probably one of the first fields where soft tissues were handled through the development of simulators, tracking of anatomical structures and specific assistance robots. However, other clinical domains, for instance urology, are concerned. Indeed, laparoscopic surgery, new tumour destruction techniques (e.g. HIFU, radiofrequency, or cryoablation), increasingly early detection of cancer, and use of interventional and diagnostic imaging modalities, recently opened new challenges to the urologist and scientists involved in CAMI. This resulted in the last five years in a very significant increase of research and developments of computer-aided urology systems. In this paper, we propose a description of the main problems related to computer-aided diagnostic and therapy of soft tissues and give a survey of the different types of assistance offered to the urologist: robotization, image fusion, surgical navigation. Both research projects and operational industrial systems are discussed

A Smartphone-Based Tool for Rapid, Portable, and Automated Wide-Field Retinal Imaging.

Purpose:High-quality, wide-field retinal imaging is a valuable method for screening preventable, vision-threatening diseases of the retina. Smartphone-based retinal cameras hold promise for increasing access to retinal imaging, but variable image quality and restricted field of view can limit their utility. We developed and clinically tested a smartphone-based system that addresses these challenges with automation-assisted imaging. Methods:The system was designed to improve smartphone retinal imaging by combining automated fixation guidance, photomontage, and multicolored illumination with optimized optics, user-tested ergonomics, and touch-screen interface. System performance was evaluated from images of ophthalmic patients taken by nonophthalmic personnel. Two masked ophthalmologists evaluated images for abnormalities and disease severity. Results:The system automatically generated 100° retinal photomontages from five overlapping images in under 1 minute at full resolution (52.3 pixels per retinal degree) fully on-phone, revealing numerous retinal abnormalities. Feasibility of the system for diabetic retinopathy (DR) screening using the retinal photomontages was performed in 71 diabetics by masked graders. DR grade matched perfectly with dilated clinical examination in 55.1% of eyes and within 1 severity level for 85.2% of eyes. For referral-warranted DR, average sensitivity was 93.3% and specificity 56.8%. Conclusions:Automation-assisted imaging produced high-quality, wide-field retinal images that demonstrate the potential of smartphone-based retinal cameras to be used for retinal disease screening. Translational Relevance:Enhancement of smartphone-based retinal imaging through automation and software intelligence holds great promise for increasing the accessibility of retinal screening

Biophotonic Tools in Cell and Tissue Diagnostics.

In order to maintain the rapid advance of biophotonics in the U.S. and enhance our competitiveness worldwide, key measurement tools must be in place. As part of a wide-reaching effort to improve the U.S. technology base, the National Institute of Standards and Technology sponsored a workshop titled "Biophotonic tools for cell and tissue diagnostics." The workshop focused on diagnostic techniques involving the interaction between biological systems and photons. Through invited presentations by industry representatives and panel discussion, near- and far-term measurement needs were evaluated. As a result of this workshop, this document has been prepared on the measurement tools needed for biophotonic cell and tissue diagnostics. This will become a part of the larger measurement road-mapping effort to be presented to the Nation as an assessment of the U.S. Measurement System. The information will be used to highlight measurement needs to the community and to facilitate solutions