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1.  e-Health, m-Health and healthier social media reform: the big scale view 
Introduction
In the upcoming decade, digital platforms will be the backbone of a strategic revolution in the way medical services are provided, affecting both healthcare providers and patients. Digital-based patient-centered healthcare services allow patients to actively participate in managing their own care, in times of health as well as illness, using personally tailored interactive tools. Such empowerment is expected to increase patients’ willingness to adopt actions and lifestyles that promote health as well as improve follow-up and compliance with treatment in cases of chronic illness. Clalit Health Services (CHS) is the largest HMO in Israel and second largest world-wide. Through its 14 hospitals, 1300 primary and specialized clinics, and 650 pharmacies, CHS provides comprehensive medical care to the majority of Israel’s population (above 4 million members). CHS e-Health wing focuses on deepening patient involvement in managing health, through personalized digital interactive tools. Currently, CHS e-Health wing provides e-health services for 1.56 million unique patients monthly with 2.4 million interactions every month (August 2011). Successful implementation of e-Health solutions is not a sum of technology, innovation and health; rather it’s the expertise of tailoring knowledge and leadership capabilities in multidisciplinary areas: clinical, ethical, psychological, legal, comprehension of patient and medical team engagement etc. The Google Health case excellently demonstrates this point. On the other hand, our success with CHS is a demonstration that e-Health can be enrolled effectively and fast with huge benefits for both patients and medical teams, and with a robust business model.
CHS e-Health core components
They include:
1. The personal health record layer (what the patient can see) presents patients with their own medical history as well as the medical history of their preadult children, including diagnoses, allergies, vaccinations, laboratory results with interpretations in layman’s terms, medications with clear, straightforward explanations regarding dosing instructions, important side effects, contraindications, such as lactation etc., and other important medical information. All personal e-Health services require identification and authorization.
2. The personal knowledge layer (what the patient should know) presents patients with personally tailored recommendations for preventative medicine and health promotion. For example, diabetic patients are push notified regarding their yearly eye exam. The various health recommendations include: occult blood testing, mammography, lipid profile etc. Each recommendation contains textual, visual and interactive content components in order to promote engagement and motivate the patient to actually change his health behaviour.
3. The personal health services layer (what the patient can do) enables patients to schedule clinic visits, order chronic prescriptions, e-consult their physician via secured e-mail, set SMS medication reminders, e-consult a pharmacist regarding personal medications. Consultants’ answers are sent securely to the patients’ personal mobile device.
On December 2009 CHS launched secured, web based, synchronous medical consultation via video conference. Currently 11,780 e-visits are performed monthly (May 2011). The medical encounter includes e-prescription and referral capabilities which are biometrically signed by the physician. On December 2010 CHS launched a unique mobile health platform, which is one of the most comprehensive personal m-Health applications world-wide. An essential advantage of mobile devices is their potential to bridge the digital divide. Currently, CHS m-Health platform is used by more than 45,000 unique users, with 75,000 laboratory results views/month, 1100 m-consultations/month and 9000 physician visit scheduling/month.
4. The Bio-Sensing layer (what physiological data the patient can populate) includes diagnostic means that allow remote physical examination, bio-sensors that broadcast various physiological measurements, and smart homecare devices, such as e-Pill boxes that gives seniors, patients and their caregivers the ability to stay at home and live life to its fullest. Monitored data is automatically transmitted to the patient’s Personal Health Record and to relevant medical personnel.
The monitoring layer is embedded in the chronic disease management platform, and in the interactive health promotion and wellness platform. It includes tailoring of consumer-oriented medical devices and service provided by various professional personnel—physicians, nurses, pharmacists, dieticians and more.
5. The Social layer (what the patient can share). Social media networks triggered an essential change at the humanity ‘genome’ level, yet to be further defined in the upcoming years. Social media has huge potential in promoting health as it combines fun, simple yet extraordinary user experience, and bio-social-feedback. There are two major challenges in leveraging health care through social networks:
a. Our personal health information is the cornerstone for personalizing healthier lifestyle, disease management and preventative medicine. We naturally see our personal health data as a super-private territory. So, how do we bring the power of our private health information, currently locked within our Personal Health Record, into social media networks without offending basic privacy issues?
b. Disease management and preventive medicine are currently neither considered ‘cool’ nor ‘fun’ or ‘potentially highly viral’ activities; yet, health is a major issue of everybody’s life. It seems like we are missing a crucial element with a huge potential in health behavioural change—the Fun Theory. Social media platforms comprehends user experience tools that potentially could break current misconception, and engage people in the daily task of taking better care of themselves.
CHS e-Health innovation team characterized several break-through applications in this unexplored territory within social media networks, fusing personal health and social media platforms without offending privacy. One of the most crucial issues regarding adoption of e-health and m-health platforms is change management. Being a ‘hot’ innovative ‘gadget’ is far from sufficient for changing health behaviours at the individual and population levels.
CHS health behaviour change management methodology includes 4 core elements:
1. Engaging two completely different populations: patients, and medical teams. e-Health applications must present true added value for both medical teams and patients, engaging them through understanding and assimilating “what’s really in it for me”. Medical teams are further subdivided into physicians, nurses, pharmacists and administrative personnel—each with their own driving incentive. Resistance to change is an obstacle in many fields but it is particularly true in the conservative health industry. To successfully manage a large scale persuasive process, we treat intra-organizational human resources as “Change Agents”. Harnessing the persuasive power of ~40,000 employees requires engaging them as the primary target group. Successful recruitment has the potential of converting each patient-medical team interaction into an exposure opportunity to the new era of participatory medicine via e-health and m-health channels.
2. Implementation waves: every group of digital health products that are released at the same time are seen as one project. Each implementation wave leverages the focus of the organization and target populations to a defined time span. There are three major and three minor implementation waves a year.
3. Change-Support Arrow: a structured infrastructure for every implementation wave. The sub-stages in this strategy include:
Cross organizational mapping and identification of early adopters and stakeholders relevant to the implementation wave
Mapping positive or negative perceptions and designing specific marketing approaches for the distinct target groups
Intra and extra organizational marketing
Conducting intensive training and presentation sessions for groups of implementers
Running conflict-prevention activities, such as advanced tackling of potential union resistance
Training change-agents with resistance-management behavioural techniques, focused intervention for specific incidents and for key opinion leaders
Extensive presence in the clinics during the launch period, etc.
The entire process is monitored and managed continuously by a review team.
4. Closing Phase: each wave is analyzed and a “lessons-learned” session concludes the changes required in the modus operandi of the e-health project team.
PMCID: PMC3571141
e-Health; mobile health; personal health record; online visit; patient empowerment; knowledge prescription
2.  Voluntary Medical Male Circumcision: A Framework Analysis of Policy and Program Implementation in Eastern and Southern Africa 
PLoS Medicine  2011;8(11):e1001133.
Kim Dickson and colleagues analyze the progress made by 13 priority countries toward scale-up of medical male circumcision programs, finding that the most successful programs involve country ownership of the program and have sustained leadership at all levels.
Background
Following confirmation of the effectiveness of voluntary medical male circumcision (VMMC) for HIV prevention, the World Health Organization and the Joint United Nations Programme on HIV/AIDS issued recommendations in 2007. Less than 5 y later, priority countries are at different stages of program scale-up. This paper analyzes the progress towards the scale-up of VMMC programs. It analyzes the adoption of VMMC as an additional HIV prevention strategy and explores the factors may have expedited or hindered the adoption of policies and initial program implementation in priority countries to date.
Methods and Findings
VMMCs performed in priority countries between 2008 and 2010 were recorded and used to classify countries into five adopter categories according to the Diffusion of Innovations framework. The main predictors of VMMC program adoption were determined and factors influencing subsequent scale-up explored. By the end of 2010, over 550,000 VMMCs had been performed, representing approximately 3% of the target coverage level in priority countries. The “early adopter” countries developed national VMMC policies and initiated VMMC program implementation soon after the release of the WHO recommendations. However, based on modeling using the Decision Makers' Program Planning Tool (DMPPT), only Kenya appears to be on track towards achievement of the DMPPT-estimated 80% coverage goal by 2015, having already achieved 61.5% of the DMPPT target. None of the other countries appear to be on track to achieve their targets. Potential predicators of early adoption of male circumcision programs include having a VMMC focal person, establishing a national policy, having an operational strategy, and the establishment of a pilot program.
Conclusions
Early adoption of VMMC policies did not necessarily result in rapid program scale-up. A key lesson is the importance of not only being ready to adopt a new intervention but also ensuring that factors critical to supporting and accelerating scale-up are incorporated into the program. The most successful program had country ownership and sustained leadership to translate research into a national policy and program.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, more than 2.5 million people (mostly in sub-Saharan Africa) become infected with HIV, the virus that causes AIDS. There is no cure for HIV/AIDS and no HIV vaccine. Consequently, global efforts to combat HIV/AIDS are concentrating on evidence-based prevention strategies such as voluntary medical male circumcision (VMMC). Circumcision—the removal of the foreskin, a loose fold of skin that covers the head of the penis—reduced HIV transmission through sexual intercourse by 60% in men in trials undertaken in sub-Saharan Africa, so in 2007, the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) recommended implementation of VMMC programs in countries with a generalized HIV epidemic and low levels of male circumcision. They also identified 13 countries in southern and eastern Africa as high priority countries for rapid VMMC scale-up. Mathematical modeling suggests that 20.3 million circumcisions by 2015 and 8.4 million circumcisions between 2016 and 2025 are needed to reach 80% VMMC coverage in these countries. If this coverage is achieved, it will avert about 3.4 million new HIV infections through 2025.
Why Was This Study Done?
Despite convincing evidence that VMMC is an effective, cost-saving intervention in the fight against HIV/AIDS, national VMMC scale-up programs in the priority countries are currently at very different stages. A better understanding of the challenges faced by these programs would help countries still in the early stages of VMMC scale-up implement their national programs and would facilitate implementation of other HIV prevention strategies. In this study, the researchers use the Diffusion of Innovations (DOI) theory to analyze progress towards VMMC scale-up in the priority countries and to identify the factors that may have expedited or hindered program scale-up. This theory seeks to explain how, why, and at what rate new ideas and technology spread through cultures. It posits that a few individuals (“innovators”) adopt new ideas before they become mainstream ideas. A few more individuals—the “early adopters”—follow the innovators. The “early majority” is the next group to adopt the innovation, followed by the “late majority” and the “laggards.”
What Did the Researchers Do and Find?
The researchers used the annual number of VMMCs performed in the priority countries since 2008 to classify the countries into DOI adopter categories. They calculated a total scale-up score for each country based on six key elements of program scale-up (such as whether and when a VMMC policy had been approved). Finally, they analyzed the association between the DOI adopter category and the scores for the individual scale-up elements to determine which elements predict adoption and VMMC scale-up. By the end of 2010, about 560,000 VMMCs had been completed, less than 3% of the target coverage for the priority countries. Kenya, the only DOI innovator country, had completed nearly two-thirds of the VMMCs needed to reach its target coverage and was the only country on track to reach its target. The early adopters (South Africa, Zambia, and Swaziland) had initiated VMMC program scale-up soon after the release of the 2007 recommendations and had started VMMC scale-up pilot programs in 2008 but were far from achieving their VMMC targets. Having a VMMC focal person, establishing a national policy, having an operational strategy, and establishing a pilot program all predicted early adoption of VMMC scale-up.
What Do These Findings Mean?
These findings show that, three years after the WHO/UNAIDS recommendation to integrate VMMC into comprehensive HIV prevention programs, VMMC scale-up activities had been initiated in all the priority countries but that progress towards the 80% coverage target was variable and generally poor. Importantly, they show that early adoption of VMMC as a national program had not necessarily resulted in rapid program scale-up. Although these findings may not be generalizable to other settings, they suggest that countries endeavoring to scale up VMMC (or other HIV prevention strategies) must not only be ready to adopt VMMC but must also ensure that all the factors critical to supporting and accelerating scale-up are incorporated into the scale-up program. Finally, these findings show that the most successful national programs are those that involve country ownership of the program and that have sustained leadership at all levels to facilitate the translation of research into national policies and programs.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001133.
This study is part of a PLoS Collection of articles on VMMC (http://www.ploscollections.org/VMMC2011) and is further discussed in a PLoS Medicine Review Article by Hankins et al. (http://dx.doi.org/10.1371/journal.pmed.1001127)
Information is available from WHO, UNAIDS, and PEPFAR on all aspects of HIV/AIDS
NAM/aidsmap provides basic information about HIV/AIDS, summaries of recent research findings on HIV care and treatment, and information on male circumcision for the prevention of HIV transmission
Information is available from Avert, an international AIDS charity on many aspects of HIV/AIDS, including information on aspects of HIV prevention, and on HIV/AIDS in Africa (in English and Spanish)
The Clearinghouse on Male Circumcision, a resource provided by WHO, UNAIDS, and other international bodies, provides information and tools for VMMC policy development and program implementation
Wikipedia has a page on Diffusion of Innovations theory (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
Personal stories about living with HIV/AIDS are available through Avert, through NAM/aidsmap, and through the charity website Healthtalkonline
doi:10.1371/journal.pmed.1001133
PMCID: PMC3226465  PMID: 22140368
3.  A model for ‘reverse innovation’ in health care 
‘Reverse innovation,’ a principle well established in the business world, describes the flow of ideas from emerging to more developed economies. There is strong and growing interest in applying this concept to health care, yet there is currently no framework for describing the stages of reverse innovation or identifying opportunities to accelerate the development process. This paper combines the business concept of reverse innovation with diffusion of innovation theory to propose a model for reverse innovation as a way to innovate in health care. Our model includes the following steps: (1) identifying a problem common to lower- and higher-income countries; (2) innovation and spread in the low-income country (LIC); (3) crossover to the higher-income country (HIC); and (4) innovation and spread in the HIC. The crucial populations in this pathway, drawing from diffusion of innovation theory, are LIC innovators, LIC early adopters, and HIC innovators. We illustrate the model with three examples of current reverse innovations. We then propose four sets of specific actions that forward-looking policymakers, entrepreneurs, health system leaders, and researchers may take to accelerate the movement of promising solutions through the reverse innovation pipeline: (1) identify high-priority problems shared by HICs and LICs; (2) create slack for change, especially for LIC innovators, LIC early adopters, and HIC innovators; (3) create spannable social distances between LIC early adopters and HIC innovators; and (4) measure reverse innovation activity globally.
doi:10.1186/1744-8603-9-40
PMCID: PMC3844499  PMID: 24001367
4.  A model for scale up of family health innovations in low-income and middle-income settings: a mixed methods study 
BMJ Open  2012;2(4):e000987.
Background
Many family health innovations that have been shown to be both efficacious and cost-effective fail to scale up for widespread use particularly in low-income and middle-income countries (LMIC). Although individual cases of successful scale-up, in which widespread take up occurs, have been described, we lack an integrated and practical model of scale-up that may be applicable to a wide range of public health innovations in LMIC.
Objective
To develop an integrated and practical model of scale-up that synthesises experiences of family health programmes in LMICs.
Data sources
We conducted a mixed methods study that included in-depth interviews with 33 key informants and a systematic review of peer-reviewed and grey literature from 11 electronic databases and 20 global health agency web sites.
Study eligibility criteria, participants and interventions
We included key informants and studies that reported on the scale up of several family health innovations including Depo-Provera as an example of a product innovation, exclusive breastfeeding as an example of a health behaviour innovation, community health workers (CHWs) as an example of an organisational innovation and social marketing as an example of a business model innovation. Key informants were drawn from non-governmental, government and international organisations using snowball sampling. An article was excluded if the article: did not meet the study's definition of the innovation; did not address dissemination, diffusion, scale up or sustainability of the innovation; did not address low-income or middle-income countries; was superficial in its discussion and/or did not provide empirical evidence about scale-up of the innovation; was not available online in full text; or was not available in English, French, Spanish or Portuguese, resulting in a final sample of 41 peer-reviewed articles and 30 grey literature sources.
Study appraisal and synthesis methods
We used the constant comparative method of qualitative data analysis to extract recurrent themes from the interviews, and we integrated these themes with findings from the literature review to generate the proposed model of scale-up. For the systematic review, screening was conducted independently by two team members to ensure consistent application of the predetermined exclusion criteria. Data extraction from the final sample of peer-reviewed and grey literature was conducted independently by two team members using a pre-established data extraction form to list the enabling factors and barriers to dissemination, diffusion, scale up and sustainability.
Results
The resulting model—the AIDED model—includes five non-linear, interrelated components: (1) assess the landscape, (2) innovate to fit user receptivity, (3) develop support, (4) engage user groups and (5) devolve efforts for spreading innovation. Our findings suggest that successful scale-up occurs within a complex adaptive system, characterised by interdependent parts, multiple feedback loops and several potential paths to achieve intended outcomes. Failure to scale up may be attributable to insufficient assessment of user groups in context, lack of fit of the innovation with user receptivity, inability to address resistance from stakeholders and inadequate engagement with user groups.
Limitations
The inductive approach used to construct the AIDED model did not allow for simultaneous empirical testing of the model. Furthermore, the literature may have publication bias in which negative studies are under-represented, although we did find examples of unsuccessful scale-up. Last, the AIDED model did not address long-term, sustained use of innovations that are successfully scaled up, which would require longer-term follow-up than is common in the literature.
Conclusions and implications of key findings
Flexible strategies of assessment, innovation, development, engagement and devolution are required to enable effective change in the use of family health innovations in LMIC.
doi:10.1136/bmjopen-2012-000987
PMCID: PMC3432850  PMID: 22923624
Health Services Administration & Management; Health policy; International health services; Public Health; Scale up
5.  Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging 
PLoS Medicine  2014;11(3):e1001629.
Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.
Please see later in the article for the Editors' Summary
Background
Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.
Methods and Findings
We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.
Conclusions
The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.
Why Was This Study Done?
The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.
What Did the Researchers Do and Find?
The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging (for example, research into social explanations of smoking behaviour) and omitted internal industry research on the role of packaging in marketing.
What Do These Findings Mean?
These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001629.
The World Health Organization provides information about the dangers of tobacco (in several languages) and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’
A UK parliamentary briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task Force
Cancer Research UK (CRUK) has a web page with information on standardised packaging and includes videos
Wikipedia has a page on standardised packaging of tobacco products (note: Wikipedia is a free online encyclopaedia that anyone can edit; available in several languages)
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulation
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001629
PMCID: PMC3965396  PMID: 24667150
6.  Technology adoption and implementation in organisations: comparative case studies of 12 English NHS Trusts 
BMJ Open  2012;2(2):e000872.
Objectives
To understand organisational technology adoption (initiation, adoption decision, implementation) by looking at the different types of innovation knowledge used during this process.
Design
Qualitative, multisite, comparative case study design.
Setting
One primary care and 11 acute care organisations (trusts) across all health regions in England in the context of infection prevention and control.
Participants and data analysis
121 semistructured individual and group interviews with 109 informants, involving clinical and non-clinical staff from all organisational levels and various professional groups. Documentary evidence and field notes were also used. 38 technology adoption processes were analysed using an integrated approach combining inductive and deductive reasoning.
Main findings
Those involved in the process variably accessed three types of innovation knowledge: ‘awareness’ (information that an innovation exists), ‘principles’ (information about an innovation's functioning principles) and ‘how-to’ (information required to use an innovation properly at individual and organisational levels). Centralised (national, government-led) and local sources were used to obtain this knowledge. Localised professional networks were preferred sources for all three types of knowledge. Professional backgrounds influenced an asymmetric attention to different types of innovation knowledge. When less attention was given to ‘how-to’ compared with ‘principles’ knowledge at the early stages of the process, this contributed to 12 cases of incomplete implementation or discontinuance after initial adoption.
Conclusions
Potential adopters and change agents often overlooked or undervalued ‘how-to’ knowledge. Balancing ‘principles’ and ‘how-to’ knowledge early in the innovation process enhanced successful technology adoption and implementation by considering efficacy as well as strategic, structural and cultural fit with the organisation's context. This learning is critical given the policy emphasis for health organisations to be innovation-ready.
Article summary
Article focus
Despite policy support and the development of a dedicated evidence dissemination infrastructure in the NHS, why is technology adoption and implementation still a challenge?
We need to understand better how the innovation process unfolds in organisations to build on what we know about individual behaviours. In particular, how the use of different types of knowledge about an innovation impacts its adoption and implementation.
Key messages
In our study, centralised dissemination of evidence had minimal to moderate impact on organisational innovation adoption decisions. Practice-based, peer-mediated and local dissemination systems were perceived more relevant.
In contrast to technology adoption by individuals, organisational adoption required a wider multifaceted conceptualisation of ‘how-to’ knowledge in line with the more complex dynamics in organisations. When ‘how-to’ knowledge was undervalued and considered late, important strategic, structural and cultural elements of the trust's context were overlooked. This had negative implications for technology adoption and implementation.
Professional backgrounds of those involved in the process influenced the types of innovation knowledge considered, which had implications for implementation. The involvement of diverse professionals in decision-making improves the chances of successful implementation through a balanced consideration of the strength of scientific evidence and practical application.
Strengths and limitations of this study
The scale of the study, its real time and longitudinal nature provide a rich data set. Our study is theory driven and comprises multisite comparative case studies, which enhance the generalisability of findings beyond the context of the studied trusts.
We explicitly studied cases of non-adoption and discontinuation after initial adoption to provide important learning often missing from innovation diffusion research.
On limitations, we were not able to follow implementation past the end of August 2010 and therefore do not have information on routinised use of the implemented technologies.
doi:10.1136/bmjopen-2012-000872
PMCID: PMC3329608  PMID: 22492183
7.  Differentiating innovation priorities among stakeholder in hospital care 
Background
Decisions to adopt a particular innovation may vary between stakeholders because individual stakeholders may disagree on the costs and benefits involved. This may translate to disagreement between stakeholders on priorities in the implementation process, possibly explaining the slow diffusion of innovations in health care. In this study, we explore the differences in stakeholder preferences for innovations, and quantify the difference in stakeholder priorities regarding costs and benefits.
Methods
The decision support technique called the analytic hierarchy process was used to quantify the preferences of stakeholders for nine information technology (IT) innovations in hospital care. The selection of the innovations was based on a literature review and expert judgments. Decision criteria related to the costs and benefits of the innovations were defined. These criteria were improvement in efficiency, health gains, satisfaction with care process, and investments required. Stakeholders judged the importance of the decision criteria and subsequently prioritized the selected IT innovations according to their expectations of how well the innovations would perform for these decision criteria.
Results
The stakeholder groups (patients, nurses, physicians, managers, health care insurers, and policy makers) had different preference structures for the innovations selected. For instance, self-tests were one of the innovations most preferred by health care insurers and managers, owing to their expected positive impacts on efficiency and health gains. However, physicians, nurses and patients strongly doubted the health gains of self-tests, and accordingly ranked self-tests as the least-preferred innovation.
Conclusions
The various stakeholder groups had different expectations of the value of the nine IT innovations. The differences are likely due to perceived stakeholder benefits of each innovation, and less to the costs to individual stakeholder groups. This study provides a first exploratory quantitative insight into stakeholder positions concerning innovation in health care, and presents a novel way to study differences in stakeholder preferences. The results may be taken into account by decision makers involved in the implementation of innovations.
doi:10.1186/1472-6947-13-91
PMCID: PMC3751765  PMID: 23947398
Implementation; Information technology; Innovation; Hospital care; Stakeholders
8.  The ethics of clinical innovation in psychopharmacology: Challenging traditional bioethics 
Objective
To assess the scientific and ethical basis for clinical innovation in psychopharmacology.
Methods
We conducted a literature review, utilizing MEDLINE search and bibliographic cross-referencing, and historical evidence regarding the discovery and development of new medications in psychiatry. Clinical innovation was defined as use of treatments in a clinical setting which have not been well-proven in a research setting.
Results
Empirical data regarding the impact of clinical innovation in psychopharmacology are lacking. A conceptual and historical assessment of this topic highlights the ethical and scientific importance of clinical innovation. Ethically, it touches a borderline that, in our judgment, is not adequately framed in contemporary mainstream bioethics. Currently, research is viewed as not at all benefiting the patients who participate in it, while clinical care is viewed as being solely for the benefit of patients. Clinical innovation straddles these two worlds, uncomfortably at times. While many argue that clinical innovation should either be avoided or folded into research projects, we argue that clinical innovation is necessary for progress in psychopharmacology research, and that it can prosper best when guided by the following ethical principles: 1.) The treatment should be based on a viable hypothesis. 2.) Whenever possible, one's clinical observations should be reported so they can be evaluated by the scientific community. 3.) One should be willing to report unexpected observations of drug effects. 4.) A high standard of informed consent should be maintained. Again, this proposal goes against the standard view among bioethicists that research and clinical care are categorically opposed activities, as made clear by the either-or dichotomy of the Belmont Report on bioethics. This approach has so polarized our profession into clinicians versus researchers, that many clinicians will not apply new knowledge produced by clinical research until it eventually gets incorporated into formal treatment guidelines, while researchers have little to guide them as to what kind of new knowledge it is most important to provide.
Summary
Clinical innovation brings out the ambiguities in our current ethical conceptions of research versus clinical care. Yet, historically, clinical innovation has been an important contributor to progress in psychopharmacology. We argue that clinical innovation should not be discouraged, but rather it should occur under certain ethical conditions.
"Almost everyone can and should do research...because almost everyone has a unique observational opportunity at some time in his life which he has an obligation to record....If one considers the fundamental operations or methods of research, one immediately realizes that most people do research at some time or another, except that they do not call their activity by that name. There are seven operations....In simple language they are counting, sorting, measuring, comparing, nature-study, guess testing, and reappraisal....Guess testing is of course what most people think of when the word research is mentioned; except that it is bad manners to call a guess a guess. It should be called an hypothesis. Let us make one plea. Guessing becomes merely a game unless it is done in the context of a plan for action. It is a waste of time elaborating untestable hypotheses [1]."
John Cade
doi:10.1186/1747-5341-2-26
PMCID: PMC2204021  PMID: 17996065
9.  How to create innovation by building the translation bridge from basic research into medicinal drugs: an industrial perspective 
Human Genomics  2013;7(1):5.
The global healthcare industry is undergoing substantial changes and adaptations to the constant decline of approved new medical entities. This decrease in internal research productivity is resulting in a major decline of patent-protected sales (patent cliff) of most of the pharmaceutical companies. Three major global adaptive trends as driving forces to cope with these challenges are evident: cut backs of internal research and development jobs in the western hemisphere (Europe and USA), following the market growth potential of Asia by building up internal or external research and development capabilities there and finally, ‘early innovation hunting’ with an increased focus on identifying and investing in very early innovation sources within academia and small start-up companies. Early innovation hunting can be done by different approaches: increased corporate funding, establishment of translational institutions to bridge innovation, increasing sponsored collaborations and formation of technology hunting groups for capturing very early scientific ideas and concepts. This emerging trend towards early innovation hunting demands special adaptations from both the pharmaceutical industry and basic researchers in academia to bridge the translation into new medicines which deliver innovative medicines that matters to the patient. This opinion article describes the different modalities of cross-fertilisation between basic university or publicly funded institutional research and the applied research and development activities within the pharmaceutical industry. Two key factors in this important translational bridge can be identified: preparation of both partnering organisations to open up for new and sometime disruptive ideas and creation of truly trust-based relationships between the different groups allowing long-term scientific collaborations while acknowledging that value-creating differences are an essential factor for successful collaboration building.
doi:10.1186/1479-7364-7-5
PMCID: PMC3608963  PMID: 23496921
Healthcare industry; Corporate venture capital; Open innovation; New frontier science; Translational development; Technology platforms
10.  Science-based health innovation in Tanzania: bednets and a base for invention 
Background
Tanzania is East Africa’s largest country. Although it is socially diverse, it has experienced general political stability since independence in 1964. Despite gradual economic development and Tanzania’s status as one of the biggest recipients of aid in Africa, health status remains poor. This paper explores Tanzania’s science-based health innovation system, and highlights areas which can be strengthened.
Methods
Qualitative case study research methodology was used. Data were collected through reviews of academic literature and policy documents, and through open-ended, face-to-face interviews with 52 people from across the science-based health innovation system over two visits to Tanzania from July to October 2007.
Results and discussion
Tanzania has a rich but complex S&T governance landscape, with the public sector driving the innovation agenda through a series of different bodies which are not well-coordinated. It has some of the leading health research on the continent at the University of Dar es Salaam, Muhimbili University of Health and Applied Sciences, the National Institute for Medical Research and the Ifakara Medical Institute, with strong donor support. Tanzania has found developing an entrepreneurial culture difficult; nevertheless projects such as the clusters initiative at the University of Dar es Salaam are encouraging low-tech innovation and overcoming knowledge-sharing barriers. In the private sector, one generics company has developed a South-South collaboration to enable technology transfer and hence the local production of anti-retrovirals. Local textile company A to Z Textiles is now manufacturing 30 million insecticide impregnated bednets a year.
Conclusions
To have a coherent vision for innovation, Tanzania may wish to address some key issues: coordination across stakeholders involved with health research, increasing graduates in health-related disciplines, and building capabilities in biological testing, preclinical testing, formulation and standardization, and related areas important to moving from basic research to applications. The private sector can be encouraged to innovate through improved access to financing, and incentives for R&D. The diaspora community represents an untapped source for partnerships and access to other developing world markets and technology. The government may wish to set up mechanisms to encourage south-south collaborations, and to bring the public and private sector together around specific projects to help realize the country’s innovation potential.
doi:10.1186/1472-698X-10-S1-S4
PMCID: PMC3001612  PMID: 21144075
11.  Turning science into health solutions: KEMRI’s challenges as Kenya’s health product pathfinder 
Background
A traditional pathway for developing new health products begins with public research institutes generating new knowledge, and ends with the private sector translating this knowledge into new ventures. But while public research institutes are key drivers of basic research in sub-Saharan Africa, the private sector is inadequately prepared to commercialize ideas that emerge from these institutes, resulting in these institutes taking on the role of product development themselves to alleviate the local disease burden. In this article, the case study method is used to analyze the experience of one such public research institute: the Kenya Medical Research Institute (KEMRI).
Discussion
Our analysis indicates that KEMRI’s product development efforts began modestly, and a manufacturing facility was constructed with a strategy for the facility’s product output which was not very successful. The intended products, HIV and Hepatitis B diagnostic kits, had a short product life cycle, and an abrupt change in regulatory requirements left KEMRI with an inactive facility. These problems were the result of poor innovation management capacity, variability in domestic markets, lack of capital to scale up technologies, and an institutional culture that lacked innovation as a priority.
However, KEMRI appears to have adapted by diversifying its product line to mitigate risk and ensure continued use of its manufacturing facility. It adopted an open innovation business model which linked it with investors, research partnerships, licensing opportunities, and revenue from contract manufacturing. Other activities that KEMRI has put in place over several years to enhance product development include the establishment of a marketing division, development of an institutional IP policy, and training of its scientists on innovation management.
Summary
KEMRI faced many challenges in its attempt at health product development, including shifting markets, lack of infrastructure, inadequate financing, and weak human capital with respect to innovation. However, it overcame them through diversification, partnerships and changes in culture. The findings could have implications for other research institutes in Sub-Saharan Africa seeking to develop health products. Such institutes must analyze potential demand and uptake, yet be prepared to face the unexpected and develop appropriate risk-mitigating strategies.
doi:10.1186/1472-698X-10-S1-S10
PMCID: PMC3001607  PMID: 21144070
12.  Procedures and Criteria for the regulation of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances 
Because great interest in an efficient range of effective medicinal innovations and achievements has arisen, many countries have introduced procedures to regulate the adoption of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances. With this as a background, this report will describe procedures for the adoption of innovative non-medicinal technologies by solidly financed health care insurances in Germany, England, Australia and Switzerland. This report was commissioned by the German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information.
In order to find the relevant literature and information, systematic literature research, a hand search and a written survey were carried out. All the selected documents (chosen according to defined criteria for inclusion and exclusion) were qualitatively evaluated, summarized and presented on a chart using a framework developed for this purpose.
All the countries in this report require that some innovative non-medicinal technologies undergo evaluation by a central governing body. This evaluation is a prerequisite for adoption into the benefit catalogue. The process of evaluation can differ (e. g. the people and institutions concerned, the division of the synthesis of evidence and overall evaluation, processing the evidence). Similarities do exist, such as the size and composition of the governing bodies or the overreaching criteria according to which institutions must make their recommendations. This is how all the countries examined in this report determine how the benefits and effectiveness of the innovations, as well as their cost-effectiveness, can be chosen as criteria for the evaluation.
Furthermore, there are many criteria which differ from country to country (social and ethical aspects, possible effects on the health system, etc.) and which are also relevant to an evaluation. The preferred types of clinical studies for these evaluations are randomized controlled trials. However, all institutions do allow for other types of evidence (e. g. expert opinion) when no other study types of a higher evidence level are available. In addition, all the countries are willing to allow unpublished or confidential information (e. g. from manufacturers) to be included in an evaluation.
It is important to remember that the decisions made by the central governing bodies do not necessarily become conditions for the introduction of innovative non-medicinal technologies. There is a host of other requirements which determine how these innovations can be introduced. This means that a large number of non-medicinal technologies make it into the medical care system via these other decision-making processes. Often, these innovations are unevaluated and differ from region to region.
Every country has established a system of observation and registration for medicinal products. These systems are meant to document any incidents with the innovations and to confer responsibility on certain organizations. All in all, no country has a central authority which systematically investigates the effects of newly introduced innovative non-medicinal technologies on medical care in general. However, Australia and England both carry out a review of innovations in some areas (e. g. by means of special commissions).
In principle, the starting point for improving regulations of innovative non-medicinal technologies lies in the extension of transparency, the shortening of decision-making time (especially the central decision-making processes), the further development of evaluation methods, more flexibility and increased capacity in the governing bodies’ decision-making processes and also, if needed, in the creation of a single authority to act as contact for people who are interested in introducing an innovation into the benefit catalogue.
More research is required, especially in the area of decentralized decision-makers and how they actually decide whether or not to introduce innovative technologies into the core care system (methods, criteria, etc.). In view of this, it would also be interesting to see how the application of innovations actually happens in practice once their adoption has been approved by the corresponding governing bodies.
PMCID: PMC3011333  PMID: 21289947
13.  Innovation in patient-centered care: lessons from a qualitative study of innovative health care organizations in Washington State 
BMC Family Practice  2012;13:120.
Background
Growing interest in the promise of patient-centered care has led to numerous health care innovations, including the patient-centered medical home, shared decision-making, and payment reforms. How best to vet and adopt innovations is an open question. Washington State has been a leader in health care reform and is a rich laboratory for patient-centered innovations. We sought to understand the process of patient-centered care innovation undertaken by innovative health care organizations – from strategic planning to goal selection to implementation to maintenance.
Methods
We conducted key-informant interviews with executives at five health plans, five provider organizations, and ten primary care clinics in Washington State. At least two readers of each interview transcript identified themes inductively; final themes were determined by consensus.
Results
Innovation in patient-centered care was a strategic objective chosen by nearly every organization in this study. However, other goals were paramount: cost containment, quality improvement, and organization survival. Organizations commonly perceived effective chronic disease management and integrated health information technology as key elements for successful patient-centered care innovation. Inertia, resource deficits, fee-for-service payment, and regulatory limits on scope of practice were cited as barriers to innovation, while organization leadership, human capital, and adaptive culture facilitated innovation.
Conclusions
Patient-centered care innovations reflected organizational perspectives: health plans emphasized cost-effectiveness while providers emphasized health care delivery processes. Health plans and providers shared many objectives, yet the two rarely collaborated to achieve them. The process of innovation is heavily dependent on organizational culture and leadership. Policymakers can improve the pace and quality of patient-centered innovation by setting targets and addressing conditions for innovation.
doi:10.1186/1471-2296-13-120
PMCID: PMC3538717  PMID: 23241305
Patient-centered care; Primary care; Health care reform
14.  Evaluating the implementation of health and safety innovations under a regulatory context: A collective case study of Ontario’s safer needle regulation 
Background
Implementation effectiveness models have identified important factors that can promote the successful implementation of an innovation; however, these models have been examined within contexts where innovations are adopted voluntarily and often ignore the socio-political and environmental context. In the field of occupational health and safety, there are circumstances where organizations must adopt innovations to comply with a regulatory standard. Examining how the external environment can facilitate or challenge an organization’s change process may add to our understanding of implementation effectiveness. The objective of this study is to describe implementation facilitators and barriers in the context of a regulation designed to promote the uptake of safer engineered medical devices in healthcare.
Methods
The proposed study will focus on Ontario’s safer needle regulation (2007) which requires healthcare organizations to transition to the use of safer engineered medical devices for the prevention of needlestick injuries. A collective case study design will be used to learn from the experiences of three acute care hospitals in the province of Ontario, Canada. Interviews with management and front-line healthcare workers and analysis of supporting documents will be used to describe the implementation experience and examine issues associated with the integration of these devices. The data collection and analysis process will be influenced by a conceptual framework that draws from implementation science and the occupational health and safety literature.
Discussion
The focus of this study in addition to the methodology creates a unique opportunity to contribute to the field of implementation science. First, the study will explore implementation experiences under circumstances where regulatory pressures are influencing the organization's change process. Second, the timing of this study provides an opportunity to focus on issues that arise during later stages of implementation, a phase during the implementation cycle that has been understudied. This study also provides the opportunity to examine the relevance and utility of current implementation science models in the field of occupational health where the adoption of an innovation is meant to enhance the health and safety of workers. Previous work has tended to focus almost exclusively on innovations that are designed to enhance an organization’s productivity or competitive advantage.
doi:10.1186/1748-5908-8-9
PMCID: PMC3556097  PMID: 23339295
Safer engineered medical devices; Regulation; Implementation; Qualitative; Case study; Hospital
15.  Optimizing Technology Development and Adoption in Medical Imaging Using the Principles of Innovation Diffusion, Part II: Practical Applications 
Journal of Digital Imaging  2011;25(1):7-10.
Successful adoption of new technology development can be accentuated by learning and applying the scientific principles of innovation diffusion. This is of particular importance to areas within the medical imaging practice which have lagged in innovation; perhaps, the most notable of which is reporting which has remained relatively stagnant for over a century. While the theoretical advantages of structured reporting have been well documented throughout the medical imaging community, adoption to date has been tepid and largely relegated to the academic and breast imaging communities. Widespread adoption will likely require an alternative approach to innovation, which addresses the heterogeneity and diversity of the practicing radiologist community along with the ever-changing expectations in service delivery. The challenges and strategies for reporting innovation and adoption are discussed, with the goal of adapting and customizing new technology to the preferences and needs of individual end-users.
doi:10.1007/s10278-011-9409-7
PMCID: PMC3264714  PMID: 21769690
Innovation adoption; Structured reporting; Medical imaging
16.  Eurocan plus report: feasibility study for coordination of national cancer research activities 
Summary
The EUROCAN+PLUS Project, called for by the European Parliament, was launched in October 2005 as a feasibility study for coordination of national cancer research activities in Europe. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people, the largest Europe–wide consultation ever conducted in the field of cancer research.
Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
It is essential to include the patients’ voice in the establishment of priority areas in cancer research at the present time. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community is evident. A top priority should be the development of translational research (in its widest form), leading to the development of effective and innovative cancer treatments and preventive strategies. Translational research ranges from bench–to–bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
The EUROCAN+PLUS Project recommends the creation of a small, permanent and independent European Cancer Initiative (ECI). This should be a model structure and was widely supported at both General Assemblies of the project. The ECI should assume responsibility for stimulating innovative cancer research and facilitating processes, becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ organizations, European institutions, Member States, industry and small and medium enterprises (SMEs), putting into practice solutions aimed at alleviating barriers to collaboration and coordination of cancer research activities in the European Union, and dealing with legal and regulatory issues. The development of an effective ECI will require time, but this entity should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co–operation between comprehensive cancer centres and basic research laboratories throughout Europe and (3) networking between funding bodies at the European level.
The European Parliament and its instruments have had a major influence in cancer control in Europe, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
Executive Summary
Cancer is one of the biggest public health crises facing Europe in the 21st century—one for which Europe is currently not prepared nor preparing itself. Cancer is a major cause of death in Europe with two million casualties and three million new cases diagnosed annually, and the situation is set to worsen as the population ages.
These facts led the European Parliament, through the Research Directorate-General of the European Commission, to call for initiatives for better coordination of cancer research efforts in the European Union. The EUROCAN+PLUS Project was launched in October 2005 as a feasibility study for coordination of national cancer research activities. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people. In this respect, the Project became the largest Europe-wide consultation ever conducted in the field of cancer research, implicating researchers, cancer centres and hospitals, administrators, healthcare professionals, funding agencies, industry, patients’ organizations and patients.
The Project first identified barriers impeding research and collaboration in research in Europe. Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain the formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
In addition, there is a shortage of leadership, a multiplicity of institutions each focusing on its own agenda, sub–optimal contact with industry, inadequate training, non–existent career paths, low personnel mobility in research especially among clinicians and inefficient funding—all conspiring against efficient collaboration in cancer care and research. European cancer research today does not have a functional translational research continuum, that is the process that exploits biomedical research innovations and converts them into prevention methods, diagnostic tools and therapies. Moreover, epidemiological research is not integrated with other types of cancer research, and the implementation of the European Directives on Clinical Trials 1 and on Personal Data Protection 2 has further slowed the innovation process in Europe. Furthermore, large inequalities in health and research exist between the EU–15 and the New Member States.
The picture is not entirely bleak, however, as the European cancer research scene presents several strengths, such as excellent basic research and clinical research and innovative etiological research that should be better exploited.
When considering recommendations, several priority dimensions had to be retained. It is essential that proposals include actions and recommendations that can benefit all Member States of the European Union and not just States with the elite centres. It is also essential to have a broader patient orientation to help provide the knowledge to establish cancer control possibilities when we exhaust what can be achieved by the implementation of current knowledge. It is vital that the actions proposed can contribute to the Lisbon Strategy to make Europe more innovative and competitive in (cancer) research.
The Project participants identified six areas for which consensus solutions should be implemented in order to obtain better coordination of cancer research activities. The required solutions are as follows. The proactive management of innovation, detection, facilitation of collaborations and maintenance of healthy competition within the European cancer research community.The establishment of an exchange portal of information for health professionals, patients and policy makers.The provision of guidance for translational and clinical research including the establishment of a translational research platform involving comprehensive cancer centres and cancer research centres.The coordination of calls and financial management of cancer research projects.The construction of a ‘one–stop shop’ as a contact interface between the industry, small and medium enterprises, scientists and other stakeholders.The support of greater involvement of healthcare professionals in translational research and multidisciplinary training.
In the course of the EUROCAN+PLUS consultative process, several key collaborative projects emerged between the various groups and institutes engaged in the consultation. There was a collaboration network established with Europe’s leading Comprehensive Cancer Centres; funding was awarded for a closer collaboration of Owners of Cancer Registries in Europe (EUROCOURSE); there was funding received from FP7 for an extensive network of leading Biological Resource Centres in Europe (BBMRI); a Working Group identified the special needs of Central, Eastern and South–eastern Europe and proposed a remedy (‘Warsaw Declaration’), and the concept of developing a one–stop shop for dealing with academia and industry including the Innovative Medicines Initiative (IMI) was discussed in detail.
Several other dimensions currently lacking were identified. There is an absolute necessity to include the patients’ voice in the establishment of priority areas in cancer research at the present time. It was a salutary lesson when it was recognized that all that is known about the quality of life of the cancer patient comes from the experience of a tiny proportion of cancer patients included in a few clinical trials. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community was evident. A top priority should be the development of translational research (in its widest form) and the development of effective and innovative cancer treatments and preventative strategies in the European Union. Translational research ranges from bench-to-bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
Having taken note of the barriers and the solutions and having examined relevant examples of existing European organizations in the field, it was agreed during the General Assembly of 19 November 2007 that the EUROCAN+PLUS Project had to recommend the creation of a small, permanent and neutral ECI. This should be a model structure and was widely supported at both General Assemblies of the project. The proposal is based on the successful model of the European Molecular Biology Organisation (EMBO), and its principal aims include providing a forum where researchers from all backgrounds and from all countries can meet with members of other specialities including patients, nurses, clinicians, funders and scientific administrators to develop priority programmes to make Europe more competitive in research and more focused on the cancer patient.
The ECI should assume responsibility for: stimulating innovative cancer research and facilitating processes;becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ and organizations;European institutions, Member States, industry and small and medium enterprises;putting into practice the aforementioned solutions aimed at alleviating barriers and coordinating cancer research activities in the EU;dealing with legal and regulatory issues.
Solutions implemented through the ECI will lead to better coordination and collaboration throughout Europe, more efficient use of resources, an increase in Europe’s attractiveness to the biomedical industry and better quality of cancer research and education of health professionals.
The Project considered that European legal instruments currently available were inadequate for addressing many aspects of the barriers identified and for the implementation of effective, lasting solutions. Therefore, the legal environment that could shelter an idea like the ECI remains to be defined but should be done so as a priority. In this context, the initiative of the European Commission for a new legal entity for research infrastructure might be a step in this direction. The development of an effective ECI will require time, but this should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass: (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co-operation between comprehensive cancer centres and basic research laboratories throughout Europe; (3) networking between funding bodies at the European level. Another topic deserving immediate attention is the creation of a European database on cancer research projects and cancer research facilities.
Despite enormous progress in cancer control in Europe during the past two decades, there was an increase of 300,000 in the number of new cases of cancer diagnosed between 2004 and 2006. The European Parliament and its instruments have had a major influence in cancer control, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
doi:10.3332/ecancer.2011.84
PMCID: PMC3234055  PMID: 22274749
17.  Designing for Diffusion: How Can We Increase Uptake of Cancer Communication Innovations? 
Patient education and counseling  2010;81(Suppl):S100-S110.
Objective
The best innovations in cancer communication do not necessarily achieve uptake by researchers, public health and clinical practitioners, and policy makers. This paper describes design activities that can be applied and combined for the purpose of spreading effective cancer communication innovations.
Methods
A previously developed Push-Pull-Infrastructure Model is used to organize and highlight the types of activities that can be deployed during the design phase of innovations. Scientific literature about the diffusion of innovations, knowledge utilization, marketing, public health, and our experiences in working to spread effective practices, programs, and policies are used for this purpose.
Results
Attempts to broaden the reach, quicken the uptake, and facilitate the use of cancer communication innovations can apply design activities to increase the likelihood of diffusion. Some simple design activities hold considerable promise for improving dissemination and subsequent diffusion.
Conclusion
Augmenting current dissemination practices with evidence-based concepts from diffusion science, marketing science, and knowledge utilization hold promise for improving results by eliciting greater market pull.
Practice Implications
Inventors and change agencies seeking to spread cancer communication innovations can experience more success by explicit consideration of design activities that reflect an expanded version of the Push-Pull-Infrastructure Model.
doi:10.1016/j.pec.2010.10.013
PMCID: PMC3000559  PMID: 21067884
18.  Factors influencing the adoption of an innovation: An examination of the uptake of the Canadian Heart Health Kit (HHK) 
Background
There is an emerging knowledge base on the effectiveness of strategies to close the knowledge-practice gap. However, less is known about how attributes of an innovation and other contextual and situational factors facilitate and impede an innovation's adoption. The Healthy Heart Kit (HHK) is a risk management and patient education resource for the prevention of cardiovascular disease (CVD) and promotion of cardiovascular health. Although previous studies have demonstrated the HHK's content validity and practical utility, no published study has examined physicians' uptake of the HHK and factors that shape its adoption.
Objectives
Conceptually informed by Rogers' Diffusion of Innovation theory, and Theory of Planned Behaviour, this study had two objectives: (1) to determine if specific attributes of the HHK as well as contextual and situational factors are associated with physicians' intention and actual usage of the HHK kit; and (2), to determine if any contextual and situational factors are associated with individual or environmental barriers that prevent the uptake of the HHK among those physicians who do not plan to use the kit.
Methods
A sample of 153 physicians who responded to an invitation letter sent to all family physicians in the province of Alberta, Canada were recruited for the study. Participating physicians were sent a HHK, and two months later a study questionnaire assessed primary factors on the physicians' clinical practice, attributes of the HHK (relative advantage, compatibility, complexity, trialability, observability), confidence and control using the HHK, barriers to use, and individual attributes. All measures were used in path analysis, employing a causal model based on Rogers' Diffusion of Innovations Theory and Theory of Planned Behaviour.
Results
115 physicians (follow up rate of 75%) completed the questionnaire. Use of the HHK was associated with intention to use the HHK, relative advantage, and years of experience. Relative advantage and the observability of the HHK benefits were also significantly associated with physicians' intention to use the HHK. Physicians working in solo medical practices reported experiencing more individual and environmental barriers to using the HHK.
Conclusion
The results of this study suggest that future information innovations must demonstrate an advantage over current resources and the research evidence supporting the innovation must be clearly visible. Findings also suggest that the innovation adoption process has a social element, and collegial interactions and discussions may facilitate that process. These results could be valuable for knowledge translation researchers and health promotion developers in future innovation adoption planning.
doi:10.1186/1748-5908-3-41
PMCID: PMC2567341  PMID: 18831766
19.  Experiences on Integrated Personal Health Systems—evidence from eight European countries 
Introduction
The current and projected rise in the ageing population and the resulting increase in chronic diseases at a time of reduced public budget expenditure are squeezing European healthcare systems. Multiple initiatives to address identified challenges emerged in Europe and serve as a test-bed for a set of policies promoting integrated care at regional and national level. England for instance with the forthcoming results on the WSD and the launch of the DALLAS programme aims to promote the use of ICT in chronic and fragile patients.
Aims
The aim of this article is to explore the role of IPHS (Integrated Personal Health Systems) in delivering integrated care in 8 selected European Member States using a three-axis framework: Innovation, Governance and Impact.
Methods
Reflecting the diversity of healthcare delivery models, eight European Member States were selected for in-depth study, namely: Denmark, Estonia, France, Germany, Italy, the Netherlands, Spain and the UK. In each of the countries, a set of experiences involving IPHS applications were identified and analysed following a regional approach.
Results
Experiences in most of the countries targeted reflect a trend moving away from pilot projects towards IPHS large scale-deployment at regional level aiming at potentially widespread diffusion at national level. Many identified drivers and barriers as well as push and pull factors are common across experiences and settings. Others are specific to each setting due to contextual factors and the nature of each health and social care system. The experiences were analysed using the three-axis framework: Innovation, Governance and Impact. Findings from an innovation perspective, for instance, identified interoperability as a barrier to be overcome. A trend towards convergence between telecare and telehealth applications was also identified. From a governance perspective, a variety of issues to be addressed was identified. Defining appropriate incentives aligned across tiers of care was identified as a governance issue to be addressed. Some experiences in Italy or Andalucía (Spain) provide interesting approaches in this regard. Further, the lack of an enabling legal framework was often translated into liability concerns for healthcare professionals. In turn, this translated into higher resistance to adopt these technologies. From an impact perspective, although evidence is often limited, this does not always prevent stakeholders from wider IPHS deployment. In addition, in some cases (i.e. Catalonia), the involvement of the HTA agency has assisted in the evaluation and dissemination of results. Thus, these organisations can play a relevant role in promoting IPHS adoption by introducing rigour into the evaluation methods and by consolidating evidence on the topic.
Conclusions
Although IPHS deployment remains limited, evidence shows that the IPHS sector is gaining momentum in Europe. The research approach using regions as the unit of analysis proved to be satisfactory. Even in countries where healthcare is highly centralised (such as France) or where strong market features in healthcare exist (such as the Netherlands), IPHS deployment seemed to be spreading following a regional model. For those interested in promoting IPHS applications, lessons learnt and policy interventions are suggested drawing on the findings.
PMCID: PMC3571162
telehealth; telecare; governance; impact; diffusion of innovation; European countries; Integrated Personal Health Systems
20.  An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice 
Trials  2012;13:78.
Background
There is a need to shed light on the pathways through which complex interventions mediate their effects in order to enable critical reflection on their transferability. We sought to explore and understand key stakeholder accounts of the acceptability, likely impact and strategies for optimizing and rolling-out a successful pharmacist-led information technology-enabled (PINCER) intervention, which substantially reduced the risk of clinically important errors in medicines management in primary care.
Methods
Data were collected at two geographical locations in central England through a combination of one-to-one longitudinal semi-structured telephone interviews (one at the beginning of the trial and another when the trial was well underway), relevant documents, and focus group discussions following delivery of the PINCER intervention. Participants included PINCER pharmacists, general practice staff, researchers involved in the running of the trial, and primary care trust staff. PINCER pharmacists were interviewed at three different time-points during the delivery of the PINCER intervention. Analysis was thematic with diffusion of innovation theory providing a theoretical framework.
Results
We conducted 52 semi-structured telephone interviews and six focus group discussions with 30 additional participants. In addition, documentary data were collected from six pharmacist diaries, along with notes from four meetings of the PINCER pharmacists and feedback meetings from 34 practices. Key findings that helped to explain the success of the PINCER intervention included the perceived importance of focusing on prescribing errors to all stakeholders, and the credibility and appropriateness of a pharmacist-led intervention to address these shortcomings. Central to this was the face-to-face contact and relationship building between pharmacists and a range of practice staff, and pharmacists’ explicitly designated role as a change agent. However, important concerns were identified about the likely sustainability of this new model of delivering care, in the absence of an appropriate support network for pharmacists and career development pathways.
Conclusions
This embedded qualitative inquiry has helped to understand the complex organizational and social environment in which the trial was undertaken and the PINCER intervention was delivered. The longitudinal element has given insight into the dynamic changes and developments over time. Medication errors and ways to address these are high on stakeholders’ agendas. Our results further indicate that pharmacists were, because of their professional standing and skill-set, able to engage with the complex general practice environment and able to identify and manage many clinically important errors in medicines management. The transferability of the PINCER intervention approach, both in relation to other prescribing errors and to other practices, is likely to be high.
doi:10.1186/1745-6215-13-78
PMCID: PMC3503703  PMID: 22682095
Qualitative evaluation; Randomized controlled trial; Pharmacist intervention; Primary care
21.  Case studies of innovative medical device companies from India: barriers and enablers to development 
Background
Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered.
Methods
Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources.
Results
In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market.
Conclusions
Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products.
doi:10.1186/1472-6963-13-199
PMCID: PMC3669049  PMID: 23721110
22.  Use of information and communication technologies to support effective work practice innovation in the health sector: a multi-site study 
Background
Widespread adoption of information and communication technologies (ICT) is a key strategy to meet the challenges facing health systems internationally of increasing demands, rising costs, limited resources and workforce shortages. Despite the rapid increase in ICT investment, uptake and acceptance has been slow and the benefits fewer than expected. Absent from the research literature has been a multi-site investigation of how ICT can support and drive innovative work practice. This Australian-based project will assess the factors that allow health service organisations to harness ICT, and the extent to which such systems drive the creation of new sustainable models of service delivery which increase capacity and provide rapid, safe, effective, affordable and sustainable health care.
Design
A multi-method approach will measure current ICT impact on workforce practices and develop and test new models of ICT use which support innovations in work practice. The research will focus on three large-scale commercial ICT systems being adopted in Australia and other countries: computerised ordering systems, ambulatory electronic medical record systems, and emergency medicine information systems. We will measure and analyse each system's role in supporting five key attributes of work practice innovation: changes in professionals' roles and responsibilities; integration of best practice into routine care; safe care practices; team-based care delivery; and active involvement of consumers in care.
Discussion
A socio-technical approach to the use of ICT will be adopted to examine and interpret the workforce and organisational complexities of the health sector. The project will also focus on ICT as a potentially disruptive innovation that challenges the way in which health care is delivered and consequently leads some health professionals to view it as a threat to traditional roles and responsibilities and a risk to existing models of care delivery. Such views have stifled debate as well as wider explorations of ICT's potential benefits, yet firm evidence of the effects of role changes on health service outcomes is limited. This project will provide important evidence about the role of ICT in supporting new models of care delivery across multiple healthcare organizations and about the ways in which innovative work practice change is diffused.
doi:10.1186/1472-6963-9-201
PMCID: PMC2776590  PMID: 19895703
23.  "Harnessing genomics to improve health in India" – an executive course to support genomics policy 
Background
The benefits of scientific medicine have eluded millions in developing countries and the genomics revolution threatens to increase health inequities between North and South. India, as a developing yet also industrialized country, is uniquely positioned to pioneer science policy innovations to narrow the genomics divide. Recognizing this, the Indian Council of Medical Research and the University of Toronto Joint Centre for Bioethics conducted a Genomics Policy Executive Course in January 2003 in Kerala, India. The course provided a forum for stakeholders to discuss the relevance of genomics for health in India. This article presents the course findings and recommendations formulated by the participants for genomics policy in India.
Methods
The course goals were to familiarize participants with the implications of genomics for health in India; analyze and debate policy and ethical issues; and develop a multi-sectoral opinion leaders' network to share perspectives. To achieve these goals, the course brought together representatives of academic research centres, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems.
Results
Seven main recommendations emerged: increase funding for healthcare research with appropriate emphasis on genomics; leverage India's assets such as traditional knowledge and genomic diversity in consultation with knowledge-holders; prioritize strategic entry points for India; improve industry-academic interface with appropriate incentives to improve public health and the nation's wealth; develop independent, accountable, transparent regulatory systems to ensure that ethical, legal and social issues are addressed for a single entry, smart and effective system; engage the public and ensure broad-based input into policy setting; ensure equitable access of poor to genomics products and services; deliver knowledge, products and services for public health. A key outcome of the course was the internet-based opinion leaders' network – the Indian Genome Policy Forum – a multi-stakeholder forum to foster further discussion on policy.
Conclusion
We expect that the process that has led to this network will serve as a model to establish similar Science and Technology policy networks on regional levels and eventually on a global level.
doi:10.1186/1478-4505-2-1
PMCID: PMC434533  PMID: 15151698
24.  Communication Strategies Must Be Tailored to a Medication's Targeted Population: Lessons from the Case of BiDil 
American Health & Drug Benefits  2013;6(7):401-412.
Background
The American population's diversity continues to grow, and its racial and ethnic mixes are changing. The US healthcare system must confront this changing reality. The introduction of isosorbide dinitrate/hydralazine hydrochloride (BiDil) to the US marketplace was a move toward recognizing these changing consumer needs. BiDil was approved specifically as a secondary treatment for heart failure in African-American patients. It remains the first and only drug approved by the US Food and Drug Administration for a race-based indication. To ensure commercial success, a drug must be made “visible” to healthcare providers and to consumers.
Objectives
To describe and analyze the case of BiDil and its potential implications for drugs developed for targeted populations to help them avoid a similar fate of market withdrawal because of commercial considerations.
Method
This analysis is based on 12 comprehensive interviews with 5 clinical investigators, 1 minority healthcare provider, and 5 pharmaceutical representatives, as well as a review of the literature. Overall, 12 one-hour semistructured interviews were conducted. Of the 11 interviewees, 10 were interviewed once and 1 was interviewed once early in the process and then had a second interview by the end of the study. When the 12 scheduled interviews were completed, the recordings were transcribed and subjected to analysis through the use of a readily available computer software package, using concepts and themes collected from the literature and the interviewees' responses.
Results
The interviewees lacked consensus regarding the unique nature of BiDil. The clinical researchers considered it innovative in identifying that taking the 2 drugs together produced the greatest clinical effect in African-American patients with heart failure. For them, BiDil represented an innovation in the emerging field of personalized medicine. However, they were dismayed to see that these beliefs were challenged by the medical community and their physician colleagues. They reported that practicing, mainly primary care physicians considered the development of a branded medication that combined 2 older drugs to be superfluous, because the same effect could be achieved by administering each agent individually at the same time. Obtaining a patent for BiDil, therefore, was seen simply as a desire for commercial gain. During the approval hearings, representatives of the sponsored company attributed these concerns to “misinformed physicians” and “uninformed patients.”
Conclusion
The case of BiDil demonstrates that a marketing strategy for a population with unique health issues requires an understanding of underlying cultural, social, and economic underpinnings. Ignorance of these dynamics within the African-American community was blatantly reflected at the launch of the drug. Although BiDil remains a treatment option, there is no marketing effort to promote its use. The failure to capture the targeted market for the drug has important implications for the future of commercial considerations in the development of race-based medications.
PMCID: PMC4031729  PMID: 24991371
25.  The Innovation Deficit in Urban Water: The Need for an Integrated Perspective on Institutions, Organizations, and Technology 
Environmental Engineering Science  2013;30(8):395-408.
Abstract
Interaction between institutional change and technological change poses important constraints on transitions of urban water systems to a state that can meet future needs. Research on urban water and other technology-dependent systems provides insights that are valuable to technology researchers interested in assuring that their efforts will have an impact. In the context of research on institutional change, innovation is the development, application, diffusion, and utilization of new knowledge and technology. This definition is intentionally inclusive: technological innovation will play a key role in reinvention of urban water systems, but is only part of what is necessary. Innovation usually depends on context, such that major changes to infrastructure include not only the technological inventions that drive greater efficiencies and physical transformations of water treatment and delivery systems, but also the political, cultural, social, and economic factors that hinder and enable such changes. On the basis of past and present changes in urban water systems, institutional innovation will be of similar importance to technological innovation in urban water reinvention. To solve current urban water infrastructure challenges, technology-focused researchers need to recognize the intertwined nature of technologies and institutions and the social systems that control change.
doi:10.1089/ees.2012.0427
PMCID: PMC3746241  PMID: 23983450
infrastructure; innovation systems; policy: sustainability; urban water

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