Bmc Med Inform Decis
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Bmc Med Inform Decis · Aug 2019
Randomized Controlled Trial Multicenter StudyThe impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: study protocol of a multicenter randomized controlled trial.
Most breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA's impact on health outcomes, explore predictors, and assess its cost-effectiveness. ⋯ This study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision.
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Bmc Med Inform Decis · Oct 2017
Multicenter Study Comparative Study Clinical TrialA study protocol of the effectiveness of PEGASUS: a multi-centred study comparing an intervention to promote shared decision making about breast reconstruction with treatment as usual.
Increasingly, women elect breast reconstruction after mastectomy. However, their expectations of surgery are often not met, and dissatisfaction with outcome and ongoing psychosocial concerns and distress are common. We developed a patient-centered intervention, PEGASUS:(Patients' Expectations and Goals: Assisting Shared Understanding of Surgery) which supports shared decision making by helping women clarify their own, individual goals about reconstruction so that they can discuss these with their surgeon. Our acceptability/feasibility work has shown it is well received by patients and health professionals alike. We now need to establish whether PEGASUS improves patients' experiences of breast reconstruction decision making and outcomes. The purpose of this study is, therefore, to examine the effectiveness of PEGASUS, an intervention designed to support shared decision making about breast reconstruction. ⋯ PEGASUS may have the potential to provide health professionals with an easily accessible tool aiming to support shared decision making and improve patients' satisfaction with breast reconstruction. Results of this study will be available at the end of 2019.
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Bmc Med Inform Decis · Aug 2017
Multicenter StudyUnsatisfactory colposcopy: clinical decision-making in conditions of uncertainty.
Unsatisfactory colposcopy, where the cells of interest are not visible in women with a positive cervical screening test, is a common area of clinical uncertainty due to the lack of clear evidence and guidance. Colposcopists' opinions and experiences are likely to have a significant influence on service provision and the development of national policy. The aim of this study was to analyse decision-making when applied to women with unsatisfactory colposcopy. ⋯ Anxiety of missing a cancer deters long-term cytological follow-up, resulting in heterogeneity of care and higher than anticipated excisional treatments in women with low-grade screening and unsatisfactory colposcopy. In areas of clinical uncertainty when decisions are dominated by affect, clinical guidance can reduce the difficulty and anxiety of decision-making.
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Bmc Med Inform Decis · Jun 2016
Multicenter StudyHow to improve vital sign data quality for use in clinical decision support systems? A qualitative study in nine Swedish emergency departments.
Vital sign data are important for clinical decision making in emergency care. Clinical Decision Support Systems (CDSS) have been advocated to increase patient safety and quality of care. However, the efficiency of CDSS depends on the quality of the underlying vital sign data. Therefore, possible factors affecting vital sign data quality need to be understood. This study aims to explore the factors affecting vital sign data quality in Swedish emergency departments and to determine in how far clinicians perceive vital sign data to be fit for use in clinical decision support systems. A further aim of the study is to provide recommendations on how to improve vital sign data quality in emergency departments. ⋯ Vital sign data quality in Swedish emergency departments is currently not fit for use by CDSS. To address both technical and organisational challenges, we propose five steps for vital sign data quality improvement to be implemented in emergency care settings.
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Bmc Med Inform Decis · Jun 2009
Multicenter StudySecurity and privacy requirements for a multi-institutional cancer research data grid: an interview-based study.
Data protection is important for all information systems that deal with human-subjects data. Grid-based systems--such as the cancer Biomedical Informatics Grid (caBIG)--seek to develop new mechanisms to facilitate real-time federation of cancer-relevant data sources, including sources protected under a variety of regulatory laws, such as HIPAA and 21CFR11. These systems embody new models for data sharing, and hence pose new challenges to the regulatory community, and to those who would develop or adopt them. These challenges must be understood by both systems developers and system adopters. In this paper, we describe our work collecting policy statements, expectations, and requirements from regulatory decision makers at academic cancer centers in the United States. We use these statements to examine fundamental assumptions regarding data sharing using data federations and grid computing. ⋯ The findings suggest that with additional work, large scale federated sharing of data within a regulated environment is possible. A key challenge is developing suitable models for authentication and authorization practices within a federated environment. Authentication--the recognition and validation of a person's identity--is in fact a global property of such systems, while authorization - the permission to access data or resources--mimics data sharing agreements in being best served at a local level. Nine specific recommendations result from the work and are discussed in detail. These include: (1) the necessity to construct separate legal or corporate entities for governance of federated sharing initiatives on this scale; (2) consensus on the treatment of foreign and commercial partnerships; (3) the development of risk models and risk management processes; (4) development of technical infrastructure to support the credentialing process associated with research including human subjects; (5) exploring the feasibility of developing large-scale, federated honest broker approaches; (6) the development of suitable, federated identity provisioning processes to support federated authentication and authorization; (7) community development of requisite HIPAA and research ethics training modules by federation members; (8) the recognition of the need for central auditing requirements and authority, and; (9) use of two-protocol data exchange models where possible in the federation.