Originally posted on “Value innovation in medical and life sciences”;
August 21th, 2009
See: http://web.archive.org/web/20101021014110/http://wp-pharma.waardeinnovatie.nl/?p=140

Telecardiology – an experimental case?

Recently, I focused on the developments in the technology of implantable pacemakers and defibrillators (http://bit.ly/8VRkZP [1]) .
I did so in the course of a consult to one of the affiliates of the cardiac devices industry in the Netherlands. I was asked to think along in the further development of cardiological care around these devices. The intention was to develop what was called as remote monitoring of cardiac devices into a design of an adequate model for integrated care in cardiology.

In preparing for this project, I was quickly amazed by the leap in progression that technology of cardiac electronic implantable devices has made in the past five decennia, since the first implant of a pacemaker. (http://tinyurl.com/yfkqhbx )
Devices as pacemakers(PM) and defibrillators(ICD) have been minimized, got external control feasibilities, and have been developed to be monitored wirelessly. Through the internet, patients with the implants can be monitored in principle anywhere and 24/7[2] (http://bit.ly/7B4NKf ). It is obvious that to do this, an elaborated system and organisation of care is needed.

A Schematic approach.
In reflection on the information I gathered, I distinguished two realms of development, each with their own dimensions. To implement the technological features to the conduct of care and benefit from its outcomes and processes, and specifically for the benefits of the patient, both realms of developments need to be actively attended to.
Both realms are certainly connected with each other. But, whereas the first is conditional to the second, the second one does not automatically follow upon the first. So, to benefit from the developed features of the devices in actual care, one needs to actively address the design and organization of care too.

The two realms of development are technology and medical care.
As each realm has three dimensions of development, both can be represented as Cubes:

The three dimensions in the technological realm are:
1) Data exchange and communication
From external and periodic control,
to possibly continuously, from one-way feed to distant inspection, to interactive, two-way and real time management;
2) Parameters and detection, monitoring
From simple and predominantly technical,
to complex and broad spectrum, and other physiological vital signs;
3) Therapeutic action
From simple stimuli in reactive response, to personal and adaptive intervention, to pattern recognition and preventive treatment.

The three dimensions in medical care:
4) Medical conduct
From therapeutic and responsive,
to adaptation to personal profiles,
to interactive prevention;
5) Organisation and management of medical treatment
From cardio clinic, specialist centred,
to multidisciplinary and third-party support, to pluralistic and patient directed;
6) Patient values
From passive, informed and non integrated, to empowered, differentiated and integrated.

With new and extra applications of technological features, consequent adaptations and arrangements need to be made in the realm of medical care. For instance: nowadays, monitoring of the signals delivered by the devices, is done in a limited way and the role of the cardiologists is rather visible. This monitoring has been delegated to specially trained nurse practitioners or allied technical co-workers. They interfere or signal the patient what to do in occurring events, or alert the responsible cardiologist[3].
So the two realms need to be in consistency with each other to benefit fully from the effects of the devices’ technology.

Developments and changes in next future.

Actual changes in care and attempts to implement forthcoming technological developments have been researched and documented.[4] Interesting specifically is a thorough research, called “FollowPace study”, initiated by prof. dr. N.M. van Hemel and aimed at documenting follow-up of pacemaker implants and patients[5]. This study also outlines the several medical treatment aspects of the implant of cardiac devices[6].

To me, three distinct steps in technological developments seem to have or, still, will have, the largest demand for consequent changes in care:
– The opportunity to monitor with or without the device recipient (possibly wirelessly): one needs to create (a) scheme(s) of actually (re)viewing the data of the patient, also in relation with setting the automatic warnings given by the device;
– The opportunity to add monitors to the device so as to follow other physiological parameters of the patient: what monitors are needed to what ends: therapeutic treatment or prevention, or which are redundant or just nice to have;
– The possibility to adapt alerts and signals from the device to the monitoring agent, the cardiologist and/or to the patients individually.

What is needed, or what are the options for a variation in signals and perhaps in symbols or codes, so that in principle complex parameters may be represented in more simple codes that are more easy to understand? Under what conditions is there an opportunity to directly inform the patient of the development of his condition, so as to act by himself on these developments? How could the patient be instructed in follow-up behaviour or possibly in self management.

The implementation of these features delineate the necessity of a departure from the current routines in handling the supervision and monitoring of the implanted electronic devices. Changes are needed that are conditional to optimize care itself and benefit patients, caregivers and other related parties like heath care payers.

So the organisation of care will need to develop further: from being centralised around the cardiologists in early days, now evolving into a multidisciplinary approach, centred around the patient from the perspective of integrated care[7]. It is not difficult to imagine how this will impact all parties involved. Prof. van Hemel describes the “electronic triangle”: the electronic traffic between patient, (monitoring) service centre and technician and/or cardiologist ..evokes the paramount question of the final responsibilities in terms of correct analysis, reaction content and reaction time, attempted reassurance and patient management followed1.

In my view an optimal design of health care is depended on the balance of three core values: medical professional values, patient values and organisation/economic values[8]. The aforementioned three departures from care routines with cardiac implants in terms of face to face controls and checks, demand a technically permitted extension of patient care. This might lead to a redesign of that care itself. The potential improvement by the technological developments of medical values and consequent patient values, need to be followed up by changes in organisation, finance and legal aspects of the way this care is realised. Of course, the effectiveness and efficiency of design chosen need to be researched, as on its health economic aspects too.

People with experience in health care will know that such further development will be difficult to bring about. Not so much by the necessity of the multidisciplinary agreement between the different disciplines and parties involved in cardiac care on itself, but also because of the implicit potential impact of changing the balance of parties’ interests inherent in it. And that is not a simple one to address. It is the question whether different parties will be able to find a new balance in their respective interests in bringing about new routines to benefit the patients’ health in an efficient way.
The related parties are now in a paradox: chaos may emerge when parties go their own way without a common reference to the benefit of all. Yet, no specific guideline is at hand, and a needed inclusive guideline (medical, technical, legal, etc.), is still far from being formulated as the needed research to found it, is in its early phases.

How to arrange for further development in practice?
So, are patients and professionals left to the small chance that the developments will go the right way? Or, yet, will enough investments be made in experimenting and researching most efficiently in order to arrive at a collective evidence based guideline? In other words: isn’t there an opportunity to construe a more structured and systematic process for this branch of health care practice to draw an effective and efficient roadmap to new standards?

This was the question to a small group of people who I was as lucky to work with: prof. N.M. van Hemel, dr. C.C. de Cock (both cardiologists), drs. Jan Elders (nurse practitioner in the arrhythmia area) and P. Boogaard (consultant), and my colleague ir. A. van den Hoek (research-consultant).
Our conclusion was that we need to get the different parties to partake in a collective branch institution to define a strategic approach for the development of the needed effective and efficient routines together: for medical conduct, the involvement of the patient, the organisation of care, legal aspects, and financial arrangement and possibly other aspects. What we envision is a systematic and scientific way of creating as quickly as possible, the best possible way of (integrated) telecardiology. This includes more than traditional guidelines, difficult enough as this is though. Although Wikipedia (http://bit.ly/8F8fPk) states that a medical protocol may address practical issues in care, it is my perception that the societal arrangements that need to be made to create adequate conditions to 24/7 telecardiology in the format of integrated care (http://bit.ly/4GtrM8) needs more research than a medical guideline might need. Not only to clinical and medical aspects, but also for the structure of responsibilities, institutional, legal, or (patient) educational and other relevant aspects.

Yet, there seems to be enough expertise to state relevant conditions, criteria and guidelines to drive developmental, experimenting projects or first practices[9]. Anyhow, it must be possible to state explicitly what not to do. First experiences and forthcoming research findings might direct and guide new practices and research indicating a new course that would seem to be most promising, most efficient and most effective for trying to create best practices.
Well, if the current available knowledge and, probably, best educated recommendations might be formulated into a frame of reference for the conduct and development of telecardiology, then the related health care society might prevent itself from wasting time, money and energy. It could also go straight onward to conduct the needed research and develop and implement projects to test this. But then, all parties would need to commit themselves to the formulated frame of references: stating that as their starting point or perhaps as code of conduct!

So we thought that the community of related parties as a branch could jumpstart the further development of telecardiology, when a formulated frame of references to the conduct of telecardiology, would act as common ground to make necessary arrangements, dispute relating interests, provide for necessary research and arrange for specific aspects of practical projects. But then the frame of references would need to have each parties’ commitment and consent! The parties involved need to express their commitment with the frame of reference explicitly. A commitment, collectively stated would render trust and identification of common goals and interests, as well as proclaim each party’s individual intentions and contributions.
When parties could create a collective, societal, consensus to this frame of references, chaos in terms of technology, quality of care, responsibilities, reimbursement and so forth, could be prevented and standards could be construed. The specific statements formulated in this frame of references could guide discussions and negotiations concerning parties’ interests to (possibly provisional) agreements to telecardiological conduct that can be implemented, researched and evaluated.
Even so, there would be opportunities to search for competing schemes within the frame of references, to stimulate for optimizing conduct of this care. Within that frame parties could look for alliances to their benefit, and in this way health care itself would benefit. By the boundaries set by the frame of references, no effort will be wasted, yet variation in vision and conduct would be welcomed to create better and feasible options. This all guaranteed by the transparency of the collective interests.
So, we defined the frame of references asa set of recommendations that parties concerned agree upon to take as their starting point when embarking on their design and set up of telecardiology.

How would we be able to arrange this?
For the convenience of cooperation, information and communication, all parties involved could assemble in an overarching institution to the branch, a platform for information, debate and exchange of interests between parties.
But the fundamental drivers for collective effort would be the collective consent with the frame of reference, yet to be formulated!

This collective consent can only be brought about, when the frame of references is formulated by an authority that is respected by all parties through a procedure in which everyone has an opportunity to participate. The authority itself must be perceived as a representation of all parties. This needs to be attended to in the construction of this authority. The same applies to the process of formulation of the frame of references.
Basically, collective commitment is based upon the opportunity to forward one’s own views and to get it appreciated in discussion, as well as the personal agreement on the outcome of the discussion. Thus, a procedure more or less open to all, directed and edited by a respected authority, must demonstrate what the main thoughts of the community for the content of the frame of references is and that these have been respected by the actual editing authority.

So, we forwarded our initiative to the different parties involved with remote monitoring of implantable devices for cardiac rhythm management, to the Netherlands Heart Rhythm Association (NHRA), a task force of the Dutch cardiology association, through them the Netherlands Society of Cardiology (NVVC), The Dutch Association of allied device technicians and nurses assisting heart stimulation and device implantation and follow-up (VITHaS), the Dutch association of patients with ICD (STIN), the affiliates of the cardiac devices industry in the Netherlands organised in the Federation of Technology Branches (FHI), and we approached the different health care insurance companies and the respective Dutch medical authorities (Ministry of Health, NzA and IGZ), as well as the Dutch Hospital Association, NVZ.
The collective ICD industry was so good as to fund our first activities to embark on our mission (resp. Medtronic, St.Jude Medical, Boston Scientific, Biotronik and the Sorin/Ela group).

What was our design of the process to lay the foundation for a successful formulation of the envisioned frame of reference?
To adhere to the critical success factors mentioned above, we set up the following design for the process of developing the frame of references:

1. We invited several professionals from the field, cardiologists and technical physiologists, to act in an editorial board that will function as the authority to formulate and actually write the frame of reference;
(we ourselves act as advisory board to the design and operations of the whole project)

2. We arranged for three conferences to all related parties:
– Exploration phase: the first meeting to document the state of the art of telecardiology and to collect opinions and views,
– Consensus phase: a second working conference to discuss and state relevant issues to the formulation of the frame of references;
– Discussion and agreement phase: a third concluding conference in which a draft of the frame of reference will be presented to the community
and probe for the communities consent.

3. A website was constructed for the registration of interested parties and individuals for information, communication and a forum of discussion.
(http://www.nhra-nft.nl/). To make sure that anyone respectful related to this endeavour (from patients to cardiologist, hospital management to health care insurers) could forward and relate to the discussion, this website functions as the platform to the process.

– Last, but central to the process is the conduct of a Delphi study. This is a research method with which visions, attitudes and opinions are collected of experts on relevant aspects regarding a specific theme. The experts respond to questionnaires in two or more rounds. Results of each round will be fed back to the experts in order to have the opportunity to revise their opinions based upon the results of earlier rounds.(Wikipedia: http://bit.ly/5tDqTJ)
Results of the Delphi study will be presented to the difference conferences so as to facilitate discussions and debate among experts from the involved parties. Dispute or reflections, to be made explicit by anyone through the website, will also be processed through the Delphi study into questionnaires for a next round and conference. The final information will be reported and submitted to the editorial committee as input to their formulation of the frame of reference.

Summary, progress and perspectives.
In essence it means that the process to arrive at the frame of reference is designed with the following criteria and steps:

  • The coordination by an independent authority, respected by the community;
  • Transparency of process and content: by use of the website to inform the respective people and to act as open platform to respond on forthcoming and evolving processes and content;
  • All parties and persons involved are invited and facilitated to identify, act and respond to activities and to get their positions acknowledged;
  • Through the integral process of the Delphi study, the conferences and the website, the necessary basis for commitment and consent from all parties is to be gradually created;
  • A process of activities, interactions and discussions is to build a potential consensus to the final document of the frame of references;
  • The possibility to follow-up the development of the final frame of reference, with the Dutch Forum on Telecardiology (NFT) as branch institution, to act as facilitating and directing institute to the actual implementation, evaluation and adaptation of the frame of reference and to reach at an inclusive guideline for telecardiology. That is if all parties consent with the institution, take part in it, and participate in the formulation process of the frame of reference.
  • In the mean time we have launched the website, the first conference has been held at November 30, 2009 and attended by nearly a 100 participants. Moreover this conference permitted to carry out the Delphi study’s first research round based on the views of the participants. (refer to the website forthcoming a review article about these data).

As of December 2009, we are now occupied to motivate all parties involved to embark on this nation wide course to make distinguishing steps to go onward with development, implementation and research in a collective and coordinated way. Chances to further financial, organisational and legal arrangement for telecardiology, related research and consequent design of improved practices are within reach due to the collective, nationwide enterprise.

We will enjoy receiving your advices and views about this process.
Please refer to the data of the author.
Thanks for taking the time to read this post.
Gratefully referring to drs. P. Boogaard, dr. C.C. de Cock, drs. J. Elders, prof. N.M. van Hemel, and ir. A. van den Hoek.

Rob Halkes, Jan. 13, 2010.

[1] Prof. N.M. van Hemel Remote monitoring of implanted cardiac devices: a plea for a nationwide exploration. [Neth Heart J2009;17(11):434]

[2] Distant monitoring is enabled through web-based technology. The coded and hidden signals from the PM/ICD device are sent to a website from the providing industry. From this station they get sent to the hospital to be received by the cardiologist or technician, who analyses, and processes the data and takes necessary steps. Patients can be monitored on a regular basis and patients with complaints can make extra transmissions.

[3] C. Eisner. Review of published evidence-based applications of telemonitoring for the surveillance of cardiac rhythm devices. Scientific Report, Graduate School of Management, Leipzig, Germany, 2008;1-16
– Ricci RP, Morichelli L, Santini M. Homemonitoring remote control of pacemakers and implantable cardioverter-defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace 2008;10:164-70.

[4] Halimi F, Clementy J, Attuel P, Dessenne X, Amara W. Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial. Europace 2008;10:1392-9.

[5] van Eck JW, van Hemel NM, de Voogt WG et al. Routine follow-up after pacemaker implantation: frequency, pacemaker programming and professionals in charge. Europace 2008;10:832-7.

[6] Van Eck J.W. , van Hemel NM, van den Bos A, Taks W, et al. Predictors of improved quality of life 1 year after pacemaker implantation. Am Heart J. 2008;156:491-7.

[7] ’Integration is a coherent set of methods and models on the funding, administrative, organisational, service delivery and clinical levels designed to create connectivity, alignment and collaboration within and between the cure and care sectors. The goal of these methods and models is to enhance quality of care and quality of life, consumer satisfaction and system efficiency for patients with complex, long-term problems cutting across multiple services, providers and settings. The result of such multi-pronged efforts to promote integration for the benefit of these special patient groups is called ‘integrated care’. Kodner Dennis L. en Spreeuwenberg, Cor. Integrated care: meaning, logic, applications and implications – a discussion paper. International Journal of Integrated Care – Vol. 2, 14,1 – 6. 2002, November.

[8] “Value Driven Health Care” naar waardevolle zorg voor gezondheid. A.R.J. Halkes Thesis for the Master of Health Administration. TiasNimbas, Tilburg 2006.

[9] E.g. ref.: Eidgenössische Kommission für allgemeine Leistungen und Grundsatzfragen, Antrag auf Kostenübernahme durch die obligatorische Krankenpflegeversicherung (OKP) betreffend der Leistung Telemonitoring in der Kardiologie: Fernüberwachung von kardiologischen Patienten und Implantaten mittels Telemonitoring. c/o Bundesamt für Gesundheit Abteilung Leistungen. Bern Mai 2008.