Cooperating on Data: The Missing Element in Bringing Real Innovation to Europe's Healthcare Systems.

Europe's growing awareness of gaps in its healthcare provision is not being matched by an increase in remedial action - despite the rich transformative potential of new approaches to data. The new availability of data offers policymakers tools that would allow Europe's huge investments in health to be far better spent, by being properly targeted. The result would be far better health for far more Europeans. But that requires a step that most European policymakers have not been ready to take. They need to cooperate so that the data can be shared and its full value realised. This paper explores the potential and the challenges that stand in the way of mobilising health data for wider health benefits. This paper goes on to summarise the results of a survey on how different components of the healthcare sector perceive the opportunities from mobilising data effectively, and the barriers to doing so. The responses demonstrated a widespread genuine will to promote research and innovation, and its take-up, for the betterment of healthcare. There was strong appreciation of the merits of data sharing and readiness - under the right circumstances - to share personal health data for research purposes and to undergo genetic sequencing. This paper also suggests the strategic direction that should influence policy formation. The solution can be found without changing the EU treaties, which already provide an adequate base for cooperation. Properly handled, the problems facing European healthcare can be turned into major assets for Europe and make it easier for citizens to have equal access to high-quality care through the meaningful use of digital innovations.

Optimising SME Potential in Modern Healthcare Systems: Challenges, Opportunities and Policy Recommendations.

The expansion of European small and medium-sized enterprises (SMEs) into the healthcare innovation arena suggests that this should be an important EU policy priority that can significantly benefit the economy, society and citizens, including patients. Deepening and widening of Europe's SMEs' growth and activities is part of the EU objectives as set out by the European Commission in its Communications "Small Business Act" for Europe [1] and "Small Business, Big World" [2]. However, innovative healthcare SMEs have struggled to get traction despite the sector being worth more than EUR 250 billion. The 1991 Maastricht Treaty gave the Union new competences in public health and more scope for cross-border cooperation in this area [3]. Nevertheless, health initiatives here have tripped over each other, due to the fact that the delivery of healthcare is a national competence [4]. As such, EU healthcare-driven policy has never truly found its footing as a singular policy area despite the fact that a tenth of the EU's GDP is spent on healthcare and more than 17 million people are employed in Europe in this sector [5]. Taking into account the necessity of bringing innovation into healthcare, and the willingness of SMEs to undertake the risk to be at the forefront of it, there is a need for a renewed effort to support SMEs so as to provide solutions for citizens and patients throughout the bloc in different healthcare settings [6]. This policy paper brings together two separate strands of analysis: firstly, a policy review of the main challenges and opportunities; secondly, a proposal for policy recommendations.

The overarching framework of translation and integration into healthcare: a case for the LAL model.

BACKGROUND: Recently, there has been a substantial increase in relevant genome-based technologies into market. Compared with its utilization in healthcare systems, we notice a huge gap. In order to address this bottleneck, we previously developed the Learning-Adapting-Leveling (LAL) model. AIM: In this article, we aim to demonstrate the overarching reach of the model for translation to market and implementation into healthcare systems moving towards personalized healthcare. METHODS: We use qualitative logical reasoning with the LAL model as a reference. RESULTS: We found that technology transfer, health needs assessment, health technology assessment and health impact assessment are justified for their inclusion. In addition, the public health wheel is justified as a good reference frame along with value of information. CONCLUSION: We conclude that as the LAL model covers all dimensions and tools for translation and implementation in a defined method; it can therefore be considered as the overarching framework for translation and implementation into healthcare.

Public health and valorization of genome-based technologies: a new model.

BACKGROUND: The success rate of timely translation of genome-based technologies to commercially feasible products/services with applicability in health care systems is significantly low. We identified both industry and scientists neglect health policy aspects when commercializing their technology, more specifically, Public Health Assessment Tools (PHAT) and early on involvement of decision makers through which market authorization and reimbursements are dependent. While Technology Transfer (TT) aims to facilitate translation of ideas into products, Health Technology Assessment, one component of PHAT, for example, facilitates translation of products/processes into healthcare services and eventually comes up with recommendations for decision makers. We aim to propose a new model of valorization to optimize integration of genome-based technologies into the healthcare system. METHODS: The method used to develop our model is an adapted version of the Fish Trap Model and the Basic Design Cycle. RESULTS: We found although different, similarities exist between TT and PHAT. Realizing the potential of being mutually beneficial justified our proposal of their relative parallel initiation. We observed that the Public Health Genomics Wheel should be included in this relative parallel activity to ensure all societal/policy aspects are dealt with preemptively by both stakeholders. On further analysis, we found out this whole process is dependent on the Value of Information. As a result, we present our LAL (Learning Adapting Leveling) model which proposes, based on market demand; TT and PHAT by consultation/bi-lateral communication should advocate for relevant technologies. This can be achieved by public-private partnerships (PPPs). These widely defined PPPs create the innovation network which is a developing, consultative/collaborative-networking platform between TT and PHAT. This network has iterations and requires learning, assimilating and using knowledge developed and is called absorption capacity. We hypothesize that the higher absorption capacity, higher success possibility. Our model however does not address the phasing out of technology although we believe the same model can be used to simultaneously phase out a technology. CONCLUSIONS: This model proposes to facilitate optimization/decrease the timeframe of integration in healthcare. It also helps industry and researchers to come to a strategic decision at an early stage, about technology being developed thus, saving on resources, hence minimizing failures.

Overestimation of complication rates in evaluations of Chlamydia trachomatis screening programmes--implications for cost-effectiveness analyses.

BACKGROUND: Cost-effectiveness analyses of screening programmes for asymptomatic Chlamydia trachomatis infection suggest that screening at low prevalences in the population is cost-effective. However, the decision models in these studies are based on assumptions about the risk of complications, which are derived from the literature. Incorrect assumptions may lead to under- or overestimation of the effectiveness of screening. The first objective of this paper is to evaluate the assumptions about the probability of complications after an asymptomatic C. trachomatis infection. The second objective is to calculate alternative rates by using available data on the incidence of complications. METHODS: We identified cost-effectiveness studies via Medline, and evaluated these for the evidence for the quoted probabilities. In addition, the probability of complications was calculated for Amsterdam from available registration data. RESULTS: In the three studies that were identified, the assumptions for the rates of pelvic inflammatory disease (PID) (clinical and subclinical) after C. trachomatis infection varied from 15% to 80%, and for ectopic pregnancy, tubal factor infertility, and chronic pelvic pain after PID from 5-25%, 10-20%, and 18-30%, respectively. The assumptions were based on data from high-risk populations, case-control data, and data not accounting for misdiagnoses. Using data obtained from local registrations, we estimated the probability of a clinical PID (0.43%), ectopic pregnancy (0.07%), and tubal factor infertility (0.02%) for women with a current infection. These estimates were consistently lower than the estimates based on the literature. CONCLUSIONS: We argue that an overestimation of the current complication rates is likely. The effect of overestimation is potentially the greatest in populations with a low prevalence, since the currently assumed cost savings associated with screening may disappear when using more realistic estimates for complications.

Cost-effectiveness of widespread screening for Chlamydia trachomatis.

Screening for sexually transmitted diseases is included in routine health care for several infectious agents in many western European countries. Current considerations on extensions of these programs include widespread screening strategies for Chlamydia trachomatis. In women, C. trachomatis infection may lead to sequelae such as infertility and ectopic pregnancy. This paper reviews the goal of screening and subsequent therapy and the available compounds for testing and treating. Furthermore, the current best practice - in particular with respect to economic performance - is discussed, and those factors that most crucially influence the economic profile are described. Illustrations are drawn from recent work in The Netherlands, which may also be representative for other settings.

Do questions on sexual behaviour and the method of sample collection affect participation in a screening programme for asymptomatic Chlamydia trachomatis infections in primary care?

We examined the effect of a questionnaire addressing sexual behaviour on participation in a systematic screening programme for asymptomatic Chlamydia trachomatis infections. Furthermore, we compared participation among persons requested to mail a home-obtained urine sample directly to the laboratory and persons requested to bring a sample to the physician's office. Seven hundred and fifty men and women were randomly assigned to receive a questionnaire with or without intimate questions and to deliver or mail the samples. The inclusion of questions about sexual behaviour did not affect participation among both men and women. Among women there was no difference in participation between delivering or mailing the sample. Among men delivering the sample, participation was 18% (95% confidence interval [CI]: 5-32) lower. This study shows that questions on sexual behaviour can be included in a screening questionnaire without adversely affecting participation. Furthermore, mailing the specimens is the most efficient strategy for men, when screening for C. trachomatis by means of home-obtained urine specimens.

The natural course of asymptomatic Chlamydia trachomatis infections: 45% clearance and no development of clinical PID after one-year follow-up.

The natural course of asymptomatic Chlamydia trachomatis infections in women was studied during one year in a cohort based nested case-control study. Healthy women (n = 744, from four company health services in Amsterdam) with a medical check-up prior to job engagement were included. C. trachomatis-positive women (n = 30, cases) and a randomly selected control group of C. trachomatis-negative women (n = 186, controls) were followed for one year. Urine specimens (at one, six and 12 months) were analysed for the presence of C. trachomatis-DNA and the C. trachomatis-serovars, and questionnaires were filled in. The C. trachomatis prevalence and natural course in relation to demographic and sexual characteristics after one, six and 12 months were studied. The main outcome measures were 1) the prevalence of C. trachomatis using urine specimens; 2) self-reported complaints; 3) clinical symptoms reported to the coordinating physicians. The prevalence of asymptomatic C. trachomatis infections was 4% and there was no correlation with demographic and sexual characteristics. The person/year clearance rate was 44.7% per year. None of the C. trachomatis-positive women developed clinical symptoms or used C. trachomatis specific antibiotic treatment. Women with or without an asymptomatic infection had the same number of self-reported urogenital complaints during follow-up. In persisting infections twice as many C. trachomatis-serovar E infections were detected as compared to clearing infections. Our findings showed that almost half of the asymptomatic C. trachomatis infections in women cleared during one year of follow-up and none developed clinical pelvic inflammatory disease (PID), which is a much lower figure than previously suggested. Therefore these data are important for cost effectiveness calculations in screening programmes for asymptomatic C. trachomatis infections.