Precision medicine: opportunities, possibilities, and challenges for patients and providers.

Precision medicine approaches disease treatment and prevention by taking patients' individual variability in genes, environment, and lifestyle into account. Although the ideas underlying precision medicine are not new, opportunities for its more widespread use in practice have been enhanced by the development of large-scale databases, new methods for categorizing and representing patients, and computational tools for analyzing large datasets. New research methods may create uncertainty for both healthcare professionals and patients. In such situations, frameworks that address ethical, legal, and social challenges can be instrumental for facilitating trust between patients and providers, but must protect patients while not stifling progress or overburdening healthcare professionals. In this perspective, we outline several ethical, legal, and social issues related to the Precision Medicine Initiative's proposed changes to current institutions, values, and frameworks. This piece is not an exhaustive overview, but is intended to highlight areas meriting further study and action, so that precision medicine's goal of facilitating systematic learning and research at the point of care does not overshadow healthcare's goal of providing care to patients.

Perspectives of Clinicians Involved in the RESTART-Study: Outcomes of a Focus Group.

PURPOSE: The purpose of this study was to explore the attitudes and beliefs of speech-language pathologists (SLPs) with regard to the Lidcombe Program and Demands and Capacities-based treatment and to examine how these attitudes and beliefs might have changed as a result of participating in the RESTART-study. METHOD: A focus group meeting with 13 SLPs was organized. The discussion was structured using questions on therapy preference, attitudes about and explicit comparison of both treatments and treatment manuals, and learnings of trial participation. RESULTS: Four main themes were identified. First, a change in attitude toward treatment choice was observed. Second, this change was related to a change in beliefs about the potential of both treatments. Third, aspects of the treatments regarded as success factors were considered. Last, learning outcomes and increased professionalism as a result of participating in the RESTART-trial were discussed. CONCLUSIONS: This study showed how attitudes and beliefs of SLPs with regard to the Lidcombe Program and Demands and Capacities-based treatment evolved during a randomized trial. This work increases our understanding of the role of attitudes and beliefs in the uptake and utilization of therapies and demonstrates the importance of collecting qualitative data. Results and recommendations should prove of value in implementing the RESTART-trial results and in training SLPs.

Developing a research agenda on ethical issues related to using social media in healthcare.

The consequences of using publicly available social media applications specifically for healthcare purposes are largely unaddressed in current research. Where they are addressed, the focus is primarily on issues of privacy and data protection. We therefore use a case study of the first live Twitter heart operation in the Netherlands, in combination with recent literature on social media from other academic fields, to identify a wide range of ethical issues related to using social media for health-related purposes. Although this case reflects an innovative approach to public education and patient centeredness, it also illustrates the need for institutions to weigh the various aspects of use and to develop a plan to deal with these on a per case basis. Given the continual development of technologies, researchers may not yet be able to oversee and anticipate all of the potential implications. Further development of a research agenda on this topic, the promotion of guidelines and policies, and the publication of case studies that reveal the granularity of individual situations will therefore help raise awareness and assist physicians and institutions in using social media to support existing care services.

Use of Online Self-Management Diaries in Asthma and COPD: A Qualitative Study of Subjects' and Professionals' Perceptions and Behaviors.

BACKGROUND: Online self-management diaries are used to support patients' self-management skills and facilitate associated behavioral changes. Although web-based diaries are well-known as a potential self-management tool, reasons that patients use (or do not use) self-management diaries, as well as perceptions and behaviors related to diary use, remain largely unknown. METHODS: Semistructured interviews (n = 30) were conducted with health-care professionals and subjects to understand perceptions and behaviors related to self-management diary use for asthma and COPD in 2 hospitals in Rotterdam, The Netherlands. RESULTS: Subjects in this study used self-management diaries to improve their knowledge of the disease, cope more consciously with their disease, feel in control, and discuss outcomes from the self-management diaries with their health-care professionals. Two subjects reported that they used the self-management diary to cope more effectively with their disease and recognized an exacerbation and acted by adjusting their medications. Both health-care professionals and subjects experienced practical barriers in integrating self-management diaries into their regular practices. Subjects' reasons for nonuse were related to the intervention, the disease, and subject-provider contact. CONCLUSIONS: Health-care professionals should help patients use self-management diaries by collaboratively developing an individual treatment plan and by showing patients how to use the diaries to recognize and act on an exacerbation. Together with the suggestions made for improving the self-management diaries, this will aid in the integration of self-management diaries into regular health-care practice and enhance patients' self-management of their disease.

The use of mystery guests by the Dutch Health Inspectorate: Results of a pilot study in long-term intramural elderly care.

This paper examines the use of 'mystery guests' as an instrument for monitoring quality and safety in healthcare. The Dutch Health Inspectorate initiated a mystery guest pilot project in elderly care as a response to political and social pressure. An independent evaluation of this project revealed that the primary goal of this approach--to provide a better view of the exigencies of daily practice in elderly care--was not met. Inspectors did not use the information delivered by the mystery guests because how they evaluated quality and reported findings did not align with practices used by the health inspectorate. Additionally, the inspectors felt that other instruments being developed were more appropriate for providing a better view of practice. While political pressure is important for effecting change in general, the specific instruments to be used for formal supervision of health institutions should be developed and implemented within the organization in accordance with existing standards and approaches. The choice to implement a new supervision instrument, including sending mystery guests into care institutions, should be preceded by an ethical analysis that takes into account the specific context of its use.

mHealth: Don't Forget All the Stakeholders in the Business Case.

Mobile health (mHealth) facilitates linking patient-generated data with electronic health records with clinical decision support systems. mHealth can transform health care, but to realize this potential it is important to identify the relevant stakeholders and how they might be affected. Such stakeholders include primary stakeholders, such as patients, families and caregivers, clinicians, health care facilities, researchers, payors and purchasers, employer, and miscellaneous secondary stakeholders, such as vendors, suppliers, distributors, and consultants, policy makers and legislators. The breadth and depth of the mHealth market make it possible for mHealth to have a considerable effect on people's health. However, many concerns exist, including privacy, data security, funding, and the lack of case studies demonstrating efficacy and cost-effectiveness. Many American and European initiatives to address these concerns are afoot.

AMIA members' "vital signs": what the HIT implementation listserv says about goals for AMIA and for medical informatics.

The health information technology (HIT) implementation listserv was conceived as a way to combine a substantial portion of American Medical Informatics Association (AMIA) members who belonged to four working groups (WGs): CIS, Evaluation, ELSI, and POI. Other AMIA members joined in significant numbers. It immediately became a major forum for discussing medical informatics, informatics policies, and discussion of the purpose of AMIA itself. The listserv membership approximates 25% of AMIA's members and has generated over 6,000 posts. We report on a survey of the listserv's members: what members think about the listserv; what participants want for medical informatics; how they think those goals should be achieved, and what AMIA's role should be in this process. The listserv provides vital signs about AMIA and hopes for informatics. We combine qualitative analysis of members' comments and responses about the listserv using ATLAS.ti qualitative text analysis tool and a word cloud generator.

Including citizens in institutional reviews: expectations and experiences from the Dutch Healthcare Inspectorate.

BACKGROUND: Recent changes in the structure and policy context of Dutch health care have placed the issue of citizen participation high on the agenda of the Dutch Healthcare Inspectorate (IGZ), which conducts quality and safety reviews in medical practices and health-care institutions. With a few exceptions, the potential role that citizens can play in the regulation of health-care institutions is overlooked in research on patient/citizen participation in health care. OBJECTIVE: This research addressed the following question: What are the (political) expectations for increasing citizen participation in health-care regulation and how do these compare to regulators' expectations and experiences in practice? DESIGN: Because of the largely explorative nature of this study, we used qualitative methods (document and web analysis, focus groups and interviews) to answer this question. RESULTS: Our study shows that inspectors already have experience with participatory formats that lead to important information. There are three areas where the IGZ is currently increasing citizen participation: (i) providing individuals with information about inspectorate processes and activities, (ii) including patients as sources of information, and (iii) formally reviewing how citizen participation is ensured by health-care institutions. In situations where the patient has the clearest overview of the whole care trajectory, intensive methods of participation deliver valuable information. CONCLUSIONS: It is important to target participation activities and to capitalize on existing opportunities and activities, rather than creating participation activities for the sake of participation. In this regard, further research on the effectiveness and efficacy of different participatory strategies is necessary.

Identifying and explaining the variability in development and implementation costs of disease management programs in the Netherlands.

BACKGROUND: In the Netherlands, disease management programs (DMPs) are used to treat chronic diseases. Their aim is to improve care and to control the rising expenditures related to chronic diseases. A bundled payment was introduced to facilitate the implementation of DMPs. This payment is an all-inclusive price per patient per year for a pre-specified care package. However, it is unclear to which extent the costs of developing and implementing DMPs are included in this price. Consequently, the organizations providing DMPs bear financial risk because the development and implementation (D&I) costs may be substantial. The aim of this paper is to investigate the variability in and drivers of D&I costs among 22 DMPs and highlight characteristics that impact these. METHODS: The data was analyzed using a mixed methods approach. Descriptive statistical analysis explored the variability in D&I costs as measured by a self-developed costing instrument and investigated the drivers. In addition, qualitative research, including document analysis and interviews, was conducted to explain the possible underlying reasons of cost variability. RESULTS: The development costs varied from €5,891 to €274,783 and the implementation costs varied from €7,278 to €387,879 across DMPs. Personnel costs were the main component of development. Development costs were strongly correlated with the implementation costs (ρ = 0.55), development duration (ρ = 0.74), and number of FTEs dedicated DMP development. Organizations with large size and high level of care prior to the implementation of a DMP had relatively low development costs. These findings were in line with the cross-case qualitative comparison where programs with a longer history, more experienced project leadership, previously established ICT systems, and less complex patient populations had lower D&I costs. CONCLUSIONS: There is wide variation in D&I costs of DMPs, which is driven primarily by the duration of the development phase and the staff needed to develop and implement a DMP. These drivers are influenced by the attributes of the DMP, characteristics of the target population, project leadership, and ICT involved. There are indications of economies of scale and economies of scope, which may reduce D&I costs.

Expert and experiential knowledge in the same place: patients' experiences with online communities connecting patients and health professionals.

OBJECTIVE: To explore patients' experiences with online health communities in which both physicians and patients participate (i.e. patient-to-doctor or 'P2D' communities). METHODS: A qualitative content analysis was conducted, based on observations in five P2D communities ranging from 8 to 21 months, and semi-structured interviews (N=17) with patients. RESULTS: Patients consider information from physicians and peers as two distinct sources, value both sources differently and appreciate accessing both in the same web space. According to respondents, physicians can provide 'reliable' and evidence-based information, while patients add experience-based information. Patients use this information for multiple purposes, including being informed about scientific research and personal reflection. CONCLUSION: Patients find P2D communities beneficial because they help patients to collect information from both medical experts and experiential experts in one place. PRACTICE IMPLICATIONS: Patients use P2D communities to perform medical, emotional and lifestyle activities. The presence of physicians in P2D communities may inadvertently suggest that the quality of information used for the activities, is controlled. When information is not officially being checked, this should be stated explicitly on the website and supplemented with a statement that information is only indicative and that patients should at all times contact their own physicians.

The role of disease management programs in the health behavior of chronically ill patients.

OBJECTIVE: Investigate the effects of disease management program (DMP) implementation on physical activity, smoking, and physical quality of life among chronically ill patients. METHODS: This study used a mixed-methods approach involving qualitative (35 interviews with project managers) and quantitative (survey of patients from 18 DMPs) data collection. Questionnaire response rates were 51% (2010; 2619/5108) at T0 and 47% (2011; 2191/4693) at T1. RESULTS: Physical activity and the percentage of smokers improved significantly over time, whereas physical quality of life declined. After adjusting for patients' physical quality of life at T0, age, educational level, marital status, and gender, physical activity at T0 (p<0.01), changes in physical activity (p<0.001), and percentage of smokers at T0 (p<0.05) predicted physical quality of life at T1. Project managers reported that DMPs improved patient-professional interaction. The ability to set more concrete targets improved patients' health behaviors. CONCLUSIONS: DMPs appear to improve physical activity among chronically ill patients over time. Furthermore, (changes in) health behavior are important for the physical quality of life of chronically ill patients. PRACTICE IMPLICATIONS: Redesigning care systems and implementing DMPs based on the chronic care model may improve health behavior among chronically ill patients.

The management of cardiovascular disease in the Netherlands: analysis of different programmes.

BACKGROUND: Disease management programmes are increasingly used to improve the efficacy and effectiveness of chronic care delivery. But, disease management programme development and implementation is a complex undertaking that requires effective decision-making. Choices made in the earliest phases of programme development are crucial, as they ultimately impact costs, outcomes and sustainability. METHODS: To increase our understanding of the choices that primary healthcare practices face when implementing such programmes and to stimulate successful implementation and sustainability, we compared the early implementation of eight cardiovascular disease management programmes initiated and managed by healthcare practices in various regions of the Netherlands. Using a mixed-methods design, we identified differences in and challenges to programme implementation in terms of context, patient characteristics, disease management level, healthcare utilisation costs, development costs and health-related quality of life. RESULTS: Shifting to a multidisciplinary, patient-centred care pathway approach to disease management is demanding for organisations, professionals and patients, and is especially vulnerable when sustainable change is the goal. Funding is an important barrier to sustainable implementation of cardiovascular disease management programmes, although development costs of the individual programmes varied considerably in relation to the length of the development period. The large number of professionals involved in combination with duration of programme development was the largest cost drivers. While Information and Communication Technology systems to support the new care pathways did not directly contribute to higher costs, delays in implementation indirectly did. CONCLUSIONS: Developing and implementing cardiovascular disease management programmes is time-consuming and challenging. Multidisciplinary, patient-centred care demands multifaceted changes in routine care. As care pathways become more complex, they also become more expensive. Better preparedness and training can prevent unnecessary delays during the implementation period and are crucial to reducing costs.

Using patient-reported experiences for pharmacovigilance?

Recent international guidelines encourage more prominent placement of patient-generated information about medications on the pharmacovigilance information landscape. Online platforms where patients share medication experiences with one another and with healthcare professionals are one possible avenue to accomplishing this goal. Public reports of medication-related events posted on the web, however, are under-utilized in the pharmacovigilance community. Moreover, little is known about who writes such reviews, what information is shared and how this information can be used by authorities. This paper reports the first results of a study of user and comment characteristics on a European-based platform.

Disease management projects and the Chronic Care Model in action: baseline qualitative research.

BACKGROUND: Disease management programs, especially those based on the Chronic Care Model (CCM), are increasingly common in The Netherlands. While disease management programs have been well-researched quantitatively and economically, less qualitative research has been done. The overall aim of the study is to explore how disease management programs are implemented within primary care settings in The Netherlands; this paper focuses on the early development and implementation stages of five disease management programs in the primary care setting, based on interviews with project leadership teams. METHODS: Eleven semi-structured interviews were conducted at the five selected sites with sixteen professionals interviewed; all project directors and managers were interviewed. The interviews focused on each project's chosen chronic illness (diabetes, eating disorders, COPD, multi-morbidity, CVRM) and project plan, barriers to development and implementation, the project leaders' action and reactions, as well as their roles and responsibilities, and disease management strategies. Analysis was inductive and interpretive, based on the content of the interviews. After analysis, the results of this research on disease management programs and the Chronic Care Model are viewed from a traveling technology framework. RESULTS: This analysis uncovered four themes that can be mapped to disease management and the Chronic Care Model: (1) changing the health care system, (2) patient-centered care, (3) technological systems and barriers, and (4) integrating projects into the larger system. Project leaders discussed the paths, both direct and indirect, for transforming the health care system to one that addresses chronic illness. Patient-centered care was highlighted as needed and a paradigm shift for many. Challenges with technological systems were pervasive. Project leaders managed the expenses of a traveling technology, including the social, financial, and administration involved. CONCLUSIONS: At the sites, project leaders served as travel guides, assisting and overseeing the programs as they traveled from the global plans to local actions. Project leaders, while hypothetically in control of the programs, in fact shared control of the traveling of the programs with patients, clinicians, and outside consultants. From this work, we can learn what roadblocks and expenses occur while a technology travels, from a project leader's point of view.

Sourcing the crowd for health services improvement: The reflexive patient and "share-your-experience" websites.

In countries where the notion of "reflexive patients" dominates the health policy landscape, patients are increasingly encouraged to publicize their personal experiences with health services provision by reviewing hospitals and professionals on the web. The number of websites where patients can review one or more aspects of their care (and read reviews posted by others) is growing. These sites are an example of the practice of crowdsourcing, where applications that facilitate user-generated content solicit feedback from a given public; site administrators then use this feedback for product development, quality improvement and policy change. The research presented here examines such developments in the context of ongoing discussions about reflexive consumerism and increased transparency in healthcare. It draws on data from a three-year study of share-your-experience sites in the U.S., U.K., and The Netherlands. Data is taken primarily from a discourse analysis of four of the six sites under study, including patient reviews of institutions and professionals (n=450). Supplementary data from interviews with stakeholders related to the Dutch sites (n=15) is also used. This is the first known study of multiple share-your-experience websites in different countries. It shows that monitoring as "reflexive" behavior is not automatic, but is encouraged by website creators who, hoping to use the posts for other purposes, act as mediators between patients and other healthcare stakeholders. It further argues that patients demonstrate more reflexivity than some stakeholders realize, although not necessarily in the way that Giddens proposed. It concludes with the argument that the focus on reflexivity in healthcare means that not only institutions must be more transparent about their performance; patients are expected to be more transparent about their choices, as well.

Use of "serious health games" in health care: a review.

This inter-disciplinary literature review examines current and potential uses of so-called "Serious Games" in health care. Based on a core body of 51 articles about Serious Games (12 pertaining specifically to health care), it briefly examines examples of use for training professionals, but focuses mostly on how games are used for patient treatment or education and how they can be used for disease prevention and health promotion. This article highlights considerations that must be made when designing and implementing Serious Games for these purposes.

Revisiting the online health information reliability debate in the wake of "web 2.0": an inter-disciplinary literature and website review.

PURPOSE: The purpose of this inter-disciplinary literature review was to explore renewed concerns about the reliability of online health information in light of the increasing popularity of web applications that enable more end-user-generated content ("web 2.0"). METHODS: The findings are based on a literature and web review. Literature was collected at four different points between October 2006 and October 2008 and included 56 sources from 10 academic disciplines. The web review consisted of following 6 blogs (including both new and archived posts, with comments) and one wiki for a period of 1.5 months and assessing the content for relevancy on six points, totaling 63 sources altogether. RESULTS: The reliability issues that are identified with respect to "web 2.0" reiterate more general concerns expressed about the web over the last 15 years. The difference, however, lies in the scope and scale of potential problems. Social scientists have also pointed to new issues that can be especially relevant for use of web 2.0 applications in health care. Specific points of renewed concern include: disclosure of authorship and information quality, anonymity and privacy, and the ability of individuals to apply information to their personal situation. Whether or not end-users understand what social scientists call "negative network externalities" is a new concern. Finally, not all reliability issues are negative-social networking and the shift from text-based information to symbolic information, images or interactive information, are considered to enhance patient education and to provide opportunities to reach diverse groups of patients. CONCLUSIONS: Interactive and collaborative web applications undeniably offer new opportunities for reaching patients and other health care consumers by facilitating lay information creation, sharing and retrieval. However, researchers must be careful and critical when incorporating applications or practices from other fields in health care. We must not easily dismiss concerns about reliability as outdated. Specific issues related to use of newly popular web applications for health purposes must be addressed. Nonetheless, the articles reviewed here also clearly show that potential problems can be addressed and the positive aspects of the technologies embraced.

Blog-based applications and health information: two case studies that illustrate important questions for Consumer Health Informatics (CHI) research.

Weblogs (blogs), together with podcasts and wikis are part of the larger body of next-generation communication applications dubbed "web 2.0." Within the specific area of health care, little attention has been devoted to understanding what applications are available to the lay public and how these are being used. In this study, a literature review on blogs and blogging practices was conducted, followed by case study analyses of two separate sites that use blogging tools to help patients and other lay web end-users record health-related experiences. This paper explores the diverse purposes for which blogging applications can be (or are being) used in relation to health and introduces the idea of "health goal-oriented" blogging. The discussion focuses on relevant informatics questions that arise with respect to the use of blogs and makes suggestions for subsequent research.

Using blogging tools to help individuals record their experiences: an exploration and review of two commercial web applications in the Netherlands.

Blogs, short for "web logs," together with podcasts and wikis are currently important foci of general internet research. These three applications are part of the larger body of next-generation communication applications that comprises "Web 2.0." Within the specific area of health care, however, little attention has been devoted to understanding these technologies and how they are being used by lay health publics. In this article, I will discuss the emergent findings from a new project that looks at blogging interfaces as potential tools for disease prevention and health promotion. I use a literature review combined with "front stage" web analyses of two cases and interviews with the supporting institutions for these sites to discuss the relevant informatics questions that arise with respect to these applications. I further introduce the idea of "goal-oriented" blogging that is found in the first case study. Because this research project is still in preliminary phases, this should be viewed as an exploration into the topic and work in progress. In addition to raising questions, I will outline the important subsequent research steps.

More than just a mouse click: research into work practices behind the assignment of medical trust marks on the World Wide Web.

Hyperlinked web trust marks have been a popular topic of discussion during the past 10 years. However, the discussion has focused mostly on what these trust marks are not doing in terms of helping patients (or other lay end users) find reliable medical information on the web. In this paper, we discuss how this focus on patients and their actions with respect to trust marks, has overshadowed, if not rendered invisible, what trust marks are doing to educate medical site/information providers. We draw on data from ethnographic research conducted at the Health on the Net Foundation in 2002 and 2003 in order to explore an alternate definition of what it means to be a 'user' of a trust mark and the importance of the review process in educating site providers. We argue that understanding the work involved in the process of assigning a seal is crucial to understanding the role that the seal plays as part of the medical internet.