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Journal of Medical Internet Research
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JMIR (ISSN: 1438-8871) is the leading Open Access journal for eHealth and healthcare in the Internet age
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Interpreting the Outcomes of Automated Internet-Based Randomized Trials:
Example of an International Smoking Cessation Study
Background: Smoking is one of the largest contributors to the global burden of disease. Internet interventions have been shown to reduce smoking rates successfully. However, improved methods of evaluating effectiveness need to be developed for large-scale Internet intervention trials. Objective: To illustrate a method to interpret outcomes of large-scale, fully automated, worldwide Internet intervention trials. Methods: A fully automated, international, Internet-based smoking cessation randomized controlled trial was conducted in Spanish and English, with 16,430 smokers from 165 countries. The randomized controlled trial replicated a published efficacy trial in which, to reduce follow-up attrition, 1000 smokers were followed up by phone if they did not provide online follow-up data. Results: The 7-day self-reported abstinence rates ranged from 36.18% (2239/6189) at 1 month to 41.34% (1361/3292) at 12 months based on observed data. Given high rates of attrition in this fully automated trial, when participants unreachable at follow-up were presumed to be smoking, the abstinence rates ranged from 13.63% (2239/16.430) at 1 month to 8.28% (1361/16,430) at 12 months. We address the problem of interpreting results with high follow-up attrition rates and propose a solution based on a smaller study with intensive phone follow-up. Conclusions: Internet-based smoking cessation interventions can help large numbers of smokers quit. Large-scale international outcome studies can be successfully implemented using automated Internet sites. Interpretation of the studies’ results can be aided by extrapolating from results obtained from subsamples that are followed up by phone or similar cohort maintenance methods. Trial Registration: ClinicalTrials.gov NCT00721786; http://clinicaltrials.gov/ct2/show/NCT00721786 (Archived by WebCite at http://www.webcitation.org/63mhoXYPw)
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Usability Evaluation of a Web-Based Support System for People With a Schizophrenia Diagnosis
Background: Routine Outcome Monitoring (ROM) is a systematic way of assessing service users’ health conditions for the purpose of better aiding their care. ROM consists of various measures used to assess a service user’s physical, psychological, and social condition. While ROM is becoming increasingly important in the mental health care sector, one of its weaknesses is that ROM is not always sufficiently service user-oriented. First, clinicians tend to concentrate on those ROM results that provide information about clinical symptoms and functioning, whereas it has been suggested that a service user-oriented approach needs to focus on personal recovery. Second, service users have limited access to ROM results and they are often not equipped to interpret them. These problems need to be addressed, as access to resources and the opportunity to share decision making has been indicated as a prerequisite for service users to become a more equal partner in communication with their clinicians. Furthermore, shared decision making has been shown to improve the therapeutic alliance and to lead to better care. Objective: Our aim is to build a web-based support system which makes ROM results more accessible to service users and to provide them with more concrete and personalized information about their functioning (ie, symptoms, housing, social contacts) that they can use to discuss treatment options with their clinician. In this study, we will report on the usability of the web-based support system for service users with schizophrenia. Methods: First, we developed a prototype of a web-based support system in a multidisciplinary project team, including end-users. We then conducted a usability study of the support system consisting of (1) a heuristic evaluation, (2) a qualitative evaluation and (3) a quantitative evaluation. Results: Fifteen service users with a schizophrenia diagnosis and four information and communication technology (ICT) experts participated in the study. The results show that people with a schizophrenia diagnosis were able to use the support system easily. Furthermore, the content of the advice generated by the support system was considered meaningful and supportive. Conclusions: This study shows that the support system prototype has valuable potential to improve the ROM practice and it is worthwhile to further develop it into a more mature system. Furthermore, the results add to prior research into web applications for people with psychotic disorders, in that it shows that this group of end users can work with web-based and computer-based systems, despite the cognitive problems they experience.
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Development and Implementation of a Web-Enabled 3D Consultation Tool for Breast Augmentation Surgery Based on 3D-Image Reconstruction of 2D Pictures
Background: Producing a rich, personalized Web-based consultation tool for plastic surgeons and patients is challenging. Objective: (1) To develop a computer tool that allows individual reconstruction and simulation of 3-dimensional (3D) soft tissue from ordinary digital photos of breasts, (2) to implement a Web-based, worldwide-accessible preoperative surgical planning platform for plastic surgeons, and (3) to validate this tool through a quality control analysis by comparing 3D laser scans of the patients with the 3D reconstructions with this tool from original 2-dimensional (2D) pictures of the same patients. Methods: The proposed system uses well-established 2D digital photos for reconstruction into a 3D torso, which is then available to the user for interactive planning. The simulation is performed on dedicated servers, accessible via Internet. It allows the surgeon, together with the patient, to previsualize the impact of the proposed breast augmentation directly during the consultation before a surgery is decided upon. We retrospectively conduced a quality control assessment of available anonymized pre- and postoperative 2D digital photographs of patients undergoing breast augmentation procedures. The method presented above was used to reconstruct 3D pictures from 2D digital pictures. We used a laser scanner capable of generating a highly accurate surface model of the patient’s anatomy to acquire ground truth data. The quality of the computed 3D reconstructions was compared with the ground truth data used to perform both qualitative and quantitative evaluations. Results: We evaluated the system on 11 clinical cases for surface reconstructions and 4 clinical cases of postoperative simulations, using laser surface scan technologies showing a mean reconstruction error between 2 and 4 mm and a maximum outlier error of 16 mm. Qualitative and quantitative analyses from plastic surgeons demonstrate the potential of these new emerging technologies. Conclusions: We tested our tool for 3D, Web-based, patient-specific consultation in the clinical scenario of breast augmentation. This example shows that the current state of development allows for creation of responsive and effective Web-based, 3D medical tools, even with highly complex and time-consuming computation, by off-loading them to a dedicated high-performance data center. The efficient combination of advanced technologies, based on analysis and understanding of human anatomy and physiology, will allow the development of further Web-based reconstruction and predictive interfaces at different scales of the human body. The consultation tool presented herein exemplifies the potential of combining advancements in the core areas of computer science and biomedical engineering with the evolving areas of Web technologies. We are confident that future developments based on a multidisciplinary approach will further pave the way toward personalized Web-enabled medicine.
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