Connecting Decision Makers with the Suppliers of New Health Intervention Technologies

• Abstract
• Introduction
• The Environment
• Scanning for Technology and Delivery
• The Current Assessment Process
• Horizon Scanning and Knowledge Management
• How Knowledge is Used Electronically in Health Systems
• International Examples
• An Idea for New Zealand
• Proposed Approach and Set Up Costs
• Hurdles to Implementation
• Critical Success factors
• Bias/Trust Issues
• Ensuring notification of the database is evenly distributed
• Governance and Funding
• Governance
• Funding
• Conclusion
• References
• Glossary
• Footnotes

Abstract
Email and Internet access have enabled models of knowledge sharing which can be of significant assistance in anticipating the impact of developments in the ever advancing arena of medical technology.

Historically, dissemination of this medical knowledge was hindered by a dependency on dispersal through lectures, tele-communications, and distribution of academic literature via paper-based journals, compounded by geographical barriers.

Today, thanks to the Internet, a wide array of worldwide medical information that is constantly being updated is available. However, because of its volume and distribution it is impossible for any individual to assimilate. Consequently, while the resource is potentially rich, its value as an aid to clinical decision-making is limited without the use of additional support systems.

To address this issue and mine the abundant body of medical technology knowledge for future potential impact, technology has emerged to provide horizon-scanning systems (HSS). Given the importance of the interpretation of this knowledge in the context of health care delivery systems these have evolved to be country specific.

These systems have become the new way of collecting and sharing information to keep researchers and practitioners worldwide informed about the latest guidelines, new technologies, best practice methods and advancing technologies at the forefront of medical change.

This paper looks at various HSS currently available worldwide and proposes how New Zealand could apply these experiences through the establishment of an innovative New Zealand centralised database to facilitate the sharing of knowledge about emerging healthcare technologies.

In particular the proposed database could improve the ability of the New Zealand health care system to anticipate future diagnostic procedures, and to assist decision-makers in assessing those emerging health technologies and forecasting how they will affect our population.

Introduction
It was a glimpse of the future when Dr "Bones" McCoy passed his Tricorder sensor over Star Trek crew members to diagnose what was wrong with them. A piece of medical technology conveying what the future might hold for people living in the 1960s.

It would be interesting to do a retrospective analysis as to whether those responsible for health systems around the world stood up and took notice (if only in part) of the potential diagnostic advancements that the imaginary Tricorder represented. Did this initiate some assessment process of new technologies coming through the medical pipeline? And would health systems accordingly budget for those laboratory tests and diagnostic procedures that the future might, in fact, start to spew forth?

The Environment
Currently in New Zealand there is no centralised horizon-scanning system (HSS) for advancing health care technologies, but rather processes have been established that help to facilitate the decision-making of, predominantly, the National Health Committee (NHC) The need for an improved process for assessing the availability and impact of new technologies has, to some extent, been acknowledged through a number of recent papers.

One of the more recent documents to date that addresses the New Zealand health technology assessment situation was published by the New Zealand NHC in a report titled "Decision-Making about New Health Interventions"^[1] in 2005. This document discusses the definitions of new health interventions with an aim of gaining consensus as to what should actually be considered by District Health Boards (DHBs) and the Ministry of Health. The NHC proposed the following criteria for this assessment: that decision-making processes facilitate timely adoption of the new intervention and are consistent with the goals of the health agency; that decision making processes add value whilst at the same time acting as a filter for those interventions which do not and; that the best decision should take into account all relevant perspectives within the limited time frame and based on currently available information.

The NHC document addresses numerous decision-making processes and also emphasises the need for good relationships between stakeholders and open communication amongst staff specialties and planning and funding arms of DHBs. The following three interconnected strategies were proposed in the paper:

1. Promote a robust decision-making process.
2. Improve national and regional decision-making processes.
3. Establish a District Health Board (DHB) run forum for decisions about emerging or high-profile interventions.

Collaboration is also heavily emphasised within the NHC paper’s executive summary which promotes the need for greater collaboration between different groups within individual DHBs, between DHBs themselves, and between DHBs and the Ministry of Health (MoH). It is of interest that nowhere does it address the need for collaboration with the private companies who actually supply new medical technology.

Another relevant document, the Service Planning and New Intervention Assessment (SPNIA) framework for collaborative decision-making was released in January 2006.^[2]

The framework draws on existing groups and structures and, where required, identifies:

new responsibilities, clearer steps, linkages and extra assistance. For example, the framework creates a clearer role for regional forums, provides assessment and analytical support to the Deputy Director-General and Chief Executive Officer (DDGCEO) Group via the new National Service and Technology Review Subcommittee (NSTR), and improves analytical support and co-ordination of sector proposals via the SPNIA analytical and process support. (p7)

The SPNIA’s national collaborative steering group was established to develop an implementation plan for DHBs and the MoH to assist in decision-making processes surrounding proposed service changes and new interventions which affect more than one DHB.

The implementation of the SPNIA framework as a form of HSS is a joint project resourced through the DHBs and District Health Boards New Zealand (DHBNZ), which has been signed off by the Minister of Health and is now ready to be put into practice. However, implementation will require a number of structures and processes to be established and managed such as: horizon scanning processes being set up by DHBs; regional forums and NSTR (National Service and Technology Review Committee) planning and submission of development plans; agreement by forums as to what should be forwarded to the NSTR, and DDG-CEO; and group decisions as to what will be incorporated into the Service Framework Group.

Scanning for Technology and Delivery
The 2005 NHC report (cited above) referred to "new health interventions" as entirely new ways of doing things and included consideration of a vast array of innovative or emerging interventions.

These can range from high tech diagnostic tools such as PET (positron emission tomography) to new genetic laboratory tests such as the Amplichip CYP450, a laboratory test that provides a comprehensive genotyping of P450 genes that allows a physician to predict a patient’s ability to metabolise certain drugs, thereby creating a more personalised approach to medicine.

The NHC report also highlighted an issue it refers to as "technology creep" which refers to a significant change in the way an intervention is performed rather than an advance in the technology itself, eg, simple metal stents in cardiology to "drug eluting" stents. It is critical that such changes are anticipated as they can have significant impact on the process and resourcing of health care delivery.

The Current Assessment Process
For the purposes of the discussion in this paper the term "new health technology" refers to diagnostic tests and devices and will exclude new interventions pertaining to pharmaceuticals.

At present there is no comprehensive national process to assess new technologies entering the market, but rather intricate "spider-web" processes involved with regional variations which enter the market at various levels. This means that there is the potential for viable and successful evidence-based technologies to be overlooked and others of less merit to be accepted dependent on the implicit and explicit priority setting techniques involved.

Horizon Scanning and Knowledge Management
The Australia and New Zealand Horizon Scanning Network (ANZHSN)^[3] website defines this process as follows:

A specialized and distinct activity conducted for a different purpose to standard HTA (Health Technology Assessment). Horizon Scanning provides, short, rapidly completed, "state of play" documents. These provide current information on technologies to alert planners and policy makers of the advent and potential impact in terms of safety and cost, before they are introduced into the health system.

This can assist planners and policy makers to control and monitor the introduction of new health technologies. It will also assist in the prioritization and allocation of resources to ensure maximum utilization of resources at least cost.

It is a way to try and collect, assimilate and communicate new information to enable more informed decisions to be made within the health sector. This would alert the current health system’s decision-makers as to where future high end costs, such as advanced diagnostic procedures, need to be budgeted for, and also analyse tests currently being performed overseas to assess the economic impact on future long-term health savings/expenditure.

How Knowledge is Used Electronically in Health Systems
The use of electronic data to share knowledge is widely dispersed throughout the medical community. It is a way for clinicians to access patient results for a variety of laboratory tests, and even imaging results such as nuclear scans, magnetic resonance imaging (MRI), computed tomography (CT) and ultrasounds.

In New Zealand, the results from any such test are recorded in patient notes (electronic patient records [EPRs]) to assist a clinician in clinical decision-making and show a clear use of knowledge sharing between laboratories, DHBs, and primary care. Recent New Zealand Health Information Service (NZHIS) data shows that more than 80,000 laboratory tests are performed daily in New Zealand. This means all of these tests are being filtered through a system and then sent via EPRs to varying physicians across the country. In fact, New Zealand has one of the highest rates of enmeshed clinical information and communication technology in the world.^[4] This commitment to knowledge sharing is supported by the 2005 Health Information Strategy for New Zealand (HIS-NZ) which was established to provide direction for the health and disability sector to enable better decision-making regarding how to improve the quality and availability of health information. The New Zealand database proposed in this paper would fit directly within this strategy.

International Examples
There are numerous international examples of working HSS which use the Internet to collate and assimilate information (see table 1).^[5] Several overseas websites have been established to assist in horizon scanning. The examples range from a simple email notification to sophisticated use of websites and web-based assessment:

• Use of simple email address to notify a national agency of any new technologies which may be of interest, include the UK National Horizon Scanning Centre^[6] and the Danish Centre for Evaluation and Health Technology Assessment.^[7] 
• An example of the more advanced websites, where there are downloadable forms companies can fill out and submit via email to the new health technology assessment unit, would include the CCOHTA^[8] (Canadian Coordinating Office for Health Technology Assessment) site’s Canadian Emerging Technologies Assessment Program (CETAP). CETAP was developed to alert health professionals about new and emerging medical technologies. This program was trialed in 1997 and upon its success became a permanent feature of the CCOHTA’s research programme to aid in data assimilation.
• An even more advanced use of the Internet is the European website Euroscan^[9] (The European Information Network on New and Changing Health Technologies), which maintains a list of companies that registered members only can access through a login page and which is constantly updated by the companies themselves to provide information on new emerging health technologies.

EuroScan was set up to enable collaboration between health technology assessment agencies to share information and evaluate emerging technologies coming through the health system and is the blueprint for the author’s proposed New Zealand database. 

Table 1: Countries and organisations operating Horizon Scanning Systems using the Internet to identify new health technologies

An Idea for New Zealand
This paper proposes to utilise the untapped knowledge that the corporate health sector possesses to create a new HSS database, to aid in the assessment of new health care technologies within the SPNIA analytical and process support algorithm (published in January 2006).^[2]

This would be achieved by establishing NICI (New Interventions – Company Information), a secure Internet database connecting decision-makers with suppliers of new health intervention technologies. NICI would only be accessible to the SPNIA convenor to provide companies with:

1. Standard questionnaire forms.
2. A portal to supply additional support information supporting the new health technology intervention, eg, clinical papers, internal assessment studies, economic analyses, etc.

Its purpose would be horizon scanning only for new diagnostic technologies/devices which may be available to the market and would not include pharmaceuticals. This is in accordance with the SPNIA assessment document which clearly states that PHARMAC (the Pharmaceutical Management Agency of New Zealand) will continue to retain full responsibility for pharmaceuticals and that there is no relationship with this body. As the author of this proposed project I support this distinction, as the decision-making processes involved in reviewing a clinical support tool such as a device or laboratory test and those required to review a therapeutic drug are quite different.

Private diagnostic and medical device companies which already have existing knowledge and expertise in future health technology interventions could submit relevant information into one centralised database, accessible to the SPNIA convenor, to assist in the national decision-making processes for new health technologies. NICI would take its place within the current (2006) SPNIA algorithm structure as represented in purple on Figure 1.

Figure 1: SPNIA analytical and process support

Proposed Approach and Set Up Costs
The proposed approach is a web-based application, loosely modelled on the successful EuroScan example. It comprises a user interface relevant to both administrators and contributors with functionality provided from a robust databse integrated with the user interface.

The establishment costs for such a site are modest. The New Zealand based company Pixel Magic,^[10] a website design and hosting company, provided a quotation of NZ$16,000 for complete set up of the NICI web site excluding hosting, maintenance and any additional updates.

Hurdles to Implementation
There are two main areas to address to successfully implement a new database such as this into the national HSS process:

1. Bias/Trust Issues.
2. Ensuring that notification of the database is evenly distributed.

These are referred to below as the critical success factors required for successful implementation of the NICI database. 

Critical Success factors

1. Bias/Trust Issues
A fundamental issue with setting up a database like NICI is that of the three-way trust paradigm between the large corporate multinational companies that submit information into the database and the population-health focused MoH and the individual DHBs.

Davenport and Prusak^[11] state that:

Without trust, knowledge management initiatives will fail regardless of how well they are supported by technology and rhetoric.

This becomes a pertinent issue when setting up NICI, where the knowledge deposited into the database comes directly from the corporate companies themselves.

Knowledge management gurus Davenport and Prusak further expanded on this topic in a recent 2006 interview in which they referred to overcoming political obstacles and issues of mistrust when setting up groundbreaking initiatives. One comment included first identifying that trust as an issue does exist. In this case, to reduce perceptions of mistrust by the DHB towards private companies may require those companies trying to work within a part of the political/health care environment for a period of time.

For diagnostic and medical device companies, trust may be less of an issue as they are accustomed to setting up contracts as suppliers to DHBs with a level of trust being one of the fundamental cornerstones to successful contract negotiations and RFPs (Request for Proposals).

Looking at the integrity of the information which NICI collects for the perusal of the SPNIA convenor is another way that mistrust may be reduced.

EuroScan confronted the challenges mentioned here such as development of public/private trust by establishing guidelines on collaboration with private industries. The guidelines were formed to ensure that the terms on how information was assimilated were acceptable to both parties involved. They also emphasise impartiality, that no gifts or hospitality should be accepted from industry, and require that, where there is a potential for private interest conflicts, a declaration must be submitted. These among other points raised in the guidelines can be transferred to the NZ HSS to ensure the reliability of the material submitted.

There are also widely acknowledged rules as to the quality of published papers in journals and in-house studies which will be entered into the database. For example: is the journal in which the information appeared highly regarded? ; is the study trial of statistical significance? ; are the numbers robust? Many journals have published on this topic, and one large recent study by Saha^[12] looked at how the Impact Factor^[a] rated against physician’s perceptions and ratings of the journal quality as seen figure 2.

Figure 2: Impact factor rated against physicians’ perceptions and ratings of the journal quality

Analysing the value of a new intervention, is not a modern concept. It was an idea identified and widely dispersed by clinical epidemiologist Archie Cochran^[13] in the 1972 book "Effectiveness and Efficiency: Random Reflections on Health Services". Three important thought processes were recognised:

1. Efficacy is the extent to which an intervention does more good than harm under ideal circumstances.
2. Effectiveness assesses whether an intervention does more good than harm when provided under usual circumstances of healthcare practice.
3. Efficiency measures the effect of an intervention in relation to the resources it consumes.

Saha^[12] and Cochran^[13] represent just two of the widely dispersed references available which examine what makes a high-quality paper. This along with the long history of identifying what goes into building superior and evidence-based medicine is a skill the appointed SPNIA convenor would possess.

2. Ensuring that notification of the database is evenly distributed
The most simplistic way to do this is via email, written letter and advertising in the main clinical journals, as well on the NHC and various MoH websites.

All Managing Directors of listed companies in the field of medical devices and diagnostics would be sent a letter to publicise the new database and invite submissions to it. Each company would also be emailed with an announcement of the database via the company’s contact details on its website. Advertising the introduction of the database in such journals as the New Zealand Medical Journal^[14] and NZ Doctor^[15] might also assist in increasing awareness of NICI.

It would be important to ensure that "announcement" of the website was made to all companies who might be able to offer submissions for technology assessment through the website.

Ensuring that notification of the website is communicated to all potential contributors would be extremely important. If this were successfully implemented, there would be a much higher level of submissions and a more robust HSS would ensue.

Governance and Funding

Governance
As previously stated, the database would be a voluntary system to enable a wide array of information to be collected to assist in horizon scanning. As the primary goal of the NICI database is to benefit the national health system of New Zealand, it should be part of a nationally recognised strategic plan that fits into the HTA (Health Technology Assessment) pathway and is supported by the MoH. In other countries, such as Canada, the HSS and HTA processes are run by one and the same organisation; it is therefore important to have that commitment from the MoH to bring the database to fruition and oversee its successful implementation.

Funding
It is envisaged that the project would be funded by the MoH. It would be inappropriate to accept financial backing from corporate companies who manufacture the medical devices/technologies which are being assessed; in fact this would contravene the Euroscan guidelines which are the blueprint for the NICI database. The funding would comprise initial set up costs, maintenance, and "announcement" of the database to corporate parties.

Conclusion
There would be numerous advantages to the establishment of the NICI database. For SPNIA, these would include an easily accessible database to which the latest reputable papers or in-house studies of statistical merit were sent directly from the companies who provide the medical diagnostics/devices. This in turn would save time and money spent on horizon scanning, and would offer a quick and more efficient way to assess what is coming through the pipeline and what may already be established overseas.

For the companies involved, security would be assured through a login page that only their top level decision makers would have access to, and it would create a direct link to the decision makers with regards to new health technologies (at present there is no centralised link). Downloadable standard application forms would create an even playing field, and because contribution to NICI would be voluntary with no cost associated with submissions, bias would also be reduced between large and smaller companies.

It is important to recognise that there may be some hesitation towards this private/public synergy. It is this author’s view that issues relating to this can be addressed, and that there are ways to utilise NICI as a horizon scanning mechanism and not as a regulatory body in an unbiased attempt to collect and assimilate a broader range of new health technology information.

In summary, NICI could be an innovative step in creating a new type of relationship between the MoH and private supply companies via knowledge sharing that could benefit the future of the New Zealand health system. If successful it could also become a model to aid in the future Australia New Zealand Therapeutic Products Authority (ANZTPA) process, a proposed regulatory scheme for therapeutic products (medicines, medical devices and complementary medicines/dietary supplements that have therapeutic uses) in both countries.

References

1. NHC (National Health Committee) Report. 2005. http://www.nhc.govt.nz/publications/PDFs/nhc-decision-making.pdf. Accessed 8 August 2006.
2. District Health Boards New Zealand Inc and Ministry of Health. Service planning and new health intervention assessment (SPNIA): framework for collaborative decisionmaking via the internet. 2006. http://www.moh.govt.nz/moh.nsf/0/059C8A39579C7B8BCC25710700746FC2/$File/service-planning.pdf. Accessed 6 August 2006.
3. Australia and New Zealand Horizon Scanning Network (ANZHSN). http://www.health.gov.au/internet/horizon/publishing.nsf/Content/process-2#what. Accessed 6 August 2006 Orr M. Evolution of New Zealand’s health knowledge management system. Brit J Healthc Comput Inf Manag 2004; 21(10): (page 3)
4. Douw K, Vondeling H, Eskildsen D, Simpson S. Use of the internet in scanning the horizon for new and emerging health technologies: a survey of agencies involved in horizon scanning. J Med Internet Res 2003 Jan–Mar;5(1):e6. Published online 31 March 2003. http://www.jmir.org/2003/1/e6/. Accessed 11 November 2006.
5. UK National Horizon Scanning Centre. http://www.pcpoh.bham.ac.uk/publichealth/horizon/. Accessed 7 August 2006.
6. Danish Centre for Evaluation and Health Technology Assessment Danish Centre for Evaluation and Health Technology Assessment. http://www.sst.dk/Planlaegning_og_behandling/Medicinsk_teknologivurdering/Tidlig_v arsling.aspx?lang=en). Accessed 6 Aug 2006.
7. Canadian site CCOHTA. http://www.cadth.ca/index.php/en/home. Accessed 8 August 2006.
8. Euroscan. http://www.euroscan.bham.ac.uk/. Accessed 8 August 2006.
9. Pixel Magic. http://www.pixelmagic.co.nz/. Accessed August 2006.
10. Davenport TH, Prusak L. Working knowledge: how organizations manage what they know. US: Harvard Business School Press; 1998.
11. Saha S, Saint S, Christakis DA. Impact factor: a valid measure of journal quality? J Med Libr Assoc 2003: 91(1):42–46.
12. Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust; 1972.
13. New Zealand Medical Journal. http://www.nzma.org.nz. Accessed August 6 2006
14. NZ Doctor. www.nzdoctor.co.nz. Accessed 12 August 2006.

Glossary

Footnotes
a Impact factor is a quantitative indicator to assess the importance of a journal; it is a measure of the frequency with which the "average article" in a journal has been cited in a particular year or period. The annual impact factor is a ratio between citations and recent citable items published. Thus, the impact factor of a journal is calculated by dividing the number of current year citations to the source items published in that journal during the previous two years.[http://scientific.thomson.com/free/essays/journalcitationreports/impactfactor/]