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Journal of Evaluation in Clinical Practice ISSN 1365-2753

Detecting deterioration in patients with chronic disease using telemonitoring: navigating the ‘trough of disillusionment’ jep_1701

896..903

Glyn Elwyn BA MB BCh MSc PhD,1 Alex R. Hardisty BSc CITP FBCS MCMI,4 Susan C. Peirce PhD,2 Carl May PhD,8 Robert Evans PhD,10 Douglas K. R. Robinson PhD,9 Charlotte E. Bolton MD,7 Zaheer Yousef MD,3 Edward C. Conley BSc PhD,5 Omer F. Rana PhD,6 W. Alex Gray MSc PhD6 and Alun D. Preece BSc PhD6 1

Professor, 2Research Associate, 3Cardiologist, Department of Primary Care and Public Health, Clinical Epidemiology Interdisciplinary Research Group, Cardiff University, Cardiff, UK 4 Director of informatics projects, 5Consortium manager, 6Professor, School of Computer Science and Informatics, Cardiff University, Cardiff, UK 7 Associate Professor, Nottingham Respiratory Biomedical Research Unit, School of Clinical Sciences, University of Nottingham, Nottingham, UK 8 Professor, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK 9 Research Scientist, Centre de Gestion Scientifique (CGS), École Nationale Supérieure des Mines de Paris, Paris, France 10 Reader in Sociology, School of Social Sciences, Cardiff University, Cardiff, UK

Keywords chronic disease, chronic illness, long-term conditions, telehealth, telemedicine, telemonitoring Correspondence Prof. Glyn Elwyn Department of Primary Care and Public Health School of Medicine Cardiff University Heath Park Cardiff CF14 4YS UK E-mail: [email protected] Accepted for publication: 28 April 2011 doi:10.1111/j.1365-2753.2011.01701.x

Abstract Objectives To examine the evidence base for telemonitoring designed for patients who have chronic obstructive pulmonary disease and heart failure, and to assess whether telemonitoring fulfils the principles of monitoring and is ready for implementation into routine settings. Design Qualitative data collection using interviews and participation in a multi-path mapping process. Participants Twenty-six purposively selected informants completed semi-structured interviews and 24 individuals with expertise in the relevant clinical and informatics domains from academia, industry, policy and provider organizations and participated in a multi-path mapping workshop. Results The evidence base for the effectiveness of telemonitoring is weak and inconsistent, with insufficient cost-effectiveness studies. When considered against an accepted definition of monitoring, telemonitoring is found wanting. Telemonitoring has not been able so far to ensure that the technologies fit into the life world of the patient and into the clinical and organizational milieu of health service delivery systems. Conclusions To develop effective telemonitoring for patients with chronic disease, more attention needs to be given to agreeing the central aim of early detection and, to ensure potential implementation, engaging a wide range of stakeholders in the design process, especially patients and clinicians.

Introduction Despite large investments over the last two decades, the use of technology to monitor patients with chronic disease has not become part of routine care [1]. Is this another example of the hype cycle, where inflated expectations lead to a ‘trough of disillusionment’ [2]? There is no doubt that health services face increasing numbers of elderly people with chronic conditions who have difficulty in predicting needs for emergency care. Detecting and treating deteriorations in chronic disease as early as possible would provide 896

benefits, especially for conditions such as heart failure and chronic obstructive pulmonary disease (COPD). Repeated decompensations in heart failure and exacerbations in COPD lead to a vicious spiral of organ damage and decline. If detection led to timely intervention, it could potentially avoid, or reduce the duration of, unplanned admissions to hospital. Measures to prevent pressure on hospital admissions would be of considerable interest. This reasoning underpins the promise of telemonitoring. Industry’s enthusiasm to develop telemonitoring technologies needs to be seen in the context of innovation in medical devices,

© 2011 Blackwell Publishing Ltd, Journal of Evaluation in Clinical Practice 18 (2012) 896–903

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especially when there are high expectations of potentially large markets [3]. Given that studies have questioned the assumption that telemonitoring initiatives are cost-effective [4–6], it is important to examine the evidence for patient benefit in the context of a high level of policy support and continued investment [7]. Is the relative weakness of research evidence a possible explanation for the low level of implementation or are there other factors to explain the lack of integration into the routines of patients, clinicians and others [1,8,9]? In addressing these issues, we need to clarify what is meant by telemonitoring. Glasziou et al. [10] defined monitoring as ‘periodic measurement that guides the management of a chronic or a recurrent condition’ and outlined five possible phases: (1) pretreatment; (2) titration of treatment; (3) maintenance of treatment (within set limits); (4) re-establishment of control (after deviation); and (5) cessation. Telemonitoring refers to the use of electronic sensor and communications’ technologies as a means of collecting data from patients, usually in their homes. Typically, this form of monitoring has focused on the maintenance phase, where the aim is to detect drift from agreed limits. Telemonitoring is therefore the addition of an integrated system of technology to the process of data collection and processing. The principles of monitoring have not been well articulated into practice and often the availability of a test or sensor has led to the collection of data while fundamental questions remain unanswered: For what reason(s) are data being collected? What data are needed and for which purpose? What will be done with the data, once collected? What will the response be to the information contained in the data and who is responsible for acting on it? Answers to these key questions are often absent or left vague in clinical practice, so it would not be surprising if parallels were found in telemonitoring [11]. Given the emphasis on early detection, it can be argued that the rationale for telemonitoring should be similar to Wilson and Jungner’s criteria for screening programmes [12]. Adapted for telemonitoring, the rationale for the early detection of deterioration in chronic disease would need to satisfy the following conditions: 1 the existence of an important and common problem; 2 a recognizable prodromal stage characteristic of an incipient deterioration; 3 the existence of measurable data variable(s) that is characteristic of this prodromal stage; 4 a process of data collection that is acceptable and feasible for patients; 5 a method for analysing the data that generates an accurate alert (reliable, sensitive and specific); and 6 a service response that leads to feasible and cost-effective interventions. If telemonitoring has been developed without giving sufficient attention to these criteria, then it is likely that translational gaps exist that match the two gaps cited in Cooksey’s review of health care research [13]. The first gap relates to whether there has been sufficient attention to the technical specification of a signal and its measurement which, if detected, could lead to a beneficial and timely intervention (conditions 1, 2 and 3 above). The second gap is related to the difficulty of getting innovations from the development laboratory into practice, or in this case, from special project into routine care (conditions 4, 5 and 6) [14]. This article reports two linked studies that examine telemonitoring for patients who have COPD and heart failure. The aim of

© 2011 Blackwell Publishing Ltd

Detecting deterioration with telemonitoring

the work was to assess whether telemonitoring adheres to the principles of monitoring and to ascertain the opinion of a range of expert stakeholders about the translation and implementation challenges that require attention.

Method We conducted literature reviews, semi-structured interviews with key informants and undertook a road-mapping exercise.

Literature reviews We adopted the following definition for telemonitoring: ‘an automated process for the transmission of data on a patient’s health status from home to the respective health care setting’ [11]. We searched for reviews, meta-analyses and health technology assessments related to the use of telemonitoring (or similar technologies) in managing patients with COPD and heart failure. This involved searching Embase, CINAHL, EBM reviews, INSPEC and Ovid MEDLINE® databases from January 2003 to May 2008 using terms such as ‘telemedicine’ and ‘telemonitoring’.

Key informant study We conducted semi-structured interviews with domain experts who had relevant medical, informatics or policy-level roles related to the use of information technology to support patients with chronic disease. We asked questions about: the best indicators (signs or symptoms) for the early detection of deterioration; when it is appropriate to initiate telemonitoring; how to collect data, analyse and store it; how to respond to alerts; what difficulties patient or clinicians face when using these systems and what questions remain unanswered. Interviews were recorded and transcribed: thematic analysis was undertaken using the constant comparison method [15]. Data about the current design and intention of telemonitoring were compared to the principles of monitoring [10].

Identifying challenges using multi-path mapping We invited individuals from academia, industry, NHS policy and NHS provider organizations who had expertise in the relevant clinical and informatics domains to engage in a day-long multipath mapping workshop, using interdisciplinary small group discussions. Multi-path mapping is a variant of ‘roadmapping’ [16] and is used for technologies at early stages of development. In this project, the process was used to identify the range of possible directions that telemonitoring could take over the next 10 years, using a number of steps. After introducing our aims, we described our focus on telemonitoring for the early detection of deterioration in COPD and heart failure. An overview of the current state of sensor devices in this area was given. In the following step, participants were asked to consider the challenges that these technologies face and which they had themselves experienced in their roles as leaders in the field. We asked them to pay attention to their ability to detect deterioration early, their acceptability to patients and others, data analysis, data security and to their impact on organizational and clinical routines. Participants were introduced 897


to the ‘Normalisation Process Theory’ (NPT) [17], a theory that predicts a technology’s capacity to become part of normal practice based on how it relates to its users and to the system that surrounds it. Participants were asked to think about challenges using four questions that are core to NPT: (1) ‘what is the (new) work that has to be done?’; (2) ‘who does the work?’; (3) ‘how does the work get done?’; and (4) ‘how is the work understood (accounted for)?’ Each group annotated their multi-path map with a set of challenges. The final step was the analysis of this data by the core research team (A. H., S. P., A .P. and G. E.).

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specialists in informatics, four senior policy advisers in informatics and four others working as consultants in engineering, informatics and the evaluation of telecare projects]. These informants identified four major failings: (1) that telemonitoring projects lack clear clinical objectives; (2) that existing devices are impractical for sustained patient use; (3) that data collection and analysis is rudimentary and not automated; and (4) that the new interprofessional relationships and medico-legal accountabilities required by telemonitoring have not been adequately considered. Lack of clinical objectives

Results Literature reviews We found a discrepancy between our adopted definition of telemonitoring and the way that most monitoring interventions for community-based patients have been implemented. Paré et al.’s definition [11] requires telemonitoring to have ‘automated processes’. However, in the majority of studies, neither data collection nor data transfer was automated. Our findings reveal that telemonitoring typically consists of asking patients to use sensor devices on a scheduled basis and to then either transmit these data to an assessment service or discuss their reports during a telephone call with a health professional. We relaxed our definition to allow the inclusion of such studies. We did not find any Cochrane-registered systematic reviews of telemonitoring interventions, for either COPD or heart failure. For COPD, we identified one recent review and meta-analysis: it does not provide substantive evidence to indicate that telemonitoring is effective at detecting deterioration or in preventing unplanned admissions [18]. We found six published reviews of telemonitoring for heart failure, indicative of much more research activity over the last decade or more [19–24]. To summarize, although the effect on mortality or hospital admission was not consistent, the majority of the reviews conclude that telemonitoring provides clinical benefit. However, the authors admit that the evidence has limitations. Many of the primary studies have design weaknesses and the work has mostly been conducted by telemonitoring advocates. For example, few studies are explicit about how monitoring data were collected and analysed to support clinical decisions. The interventions are heterogeneous (from telephone call support to Web-based data entry by patients) and the majority of studies have underpowered samples and short follow-up durations. The risk of bias is therefore considerable. Overall, there is insufficient evidence to make categorical judgements about the clinical effectiveness of telemonitoring and there is no confirmation that the interventions are cost-effective, as currently conceptualized, for patients with COPD or heart failure. In reviewing this literature, although we found many trials of telemonitoring, but could not find any long-term evaluations and there is no indication that telemonitoring for these two chronic conditions has become an established part of routine clinical services.

Key informant study We interviewed 26 informants with clinical and informatics experience [five nurses working in telemonitoring projects, six specialists (heart failure and COPD), one general practitioner, six 898

Informants stated that telemonitoring is often introduced on an ad hoc basis and that the system is determined more by the availability of sensor devices than by specified clinical aims. They reported that the provision of feedback from telemonitoring systems to patients was almost non-existent, despite a general acknowledgement that effective patient self-management is essential in longterm conditions. Variables chosen for monitoring are typically heart rate, blood pressure, weight, temperature and, sometimes, oxygen saturation, supplemented with symptom questions or scores, with little effort to specify these to the early detection of deterioration. Informants argued that the identification of a clinical goal needs to be more clearly agreed so that telemonitoring has more focus on a specific patient benefit. For example, the identification of incipient heart failure could lead to rapid assessment and intervention. However, informants noted that there is no consensus among clinical professionals about what constitutes the diagnostic characteristics for impending heart failure (nor for early signs of a COPD exacerbation). In short, telemonitoring is not directed towards the early detection of impending problems. Impractical for patient use Existing telemonitoring sensor devices are cumbersome especially for individuals with reduced mobility or cognitive impairment, and data collection relies on patients using them at set times in a single location. Informants indicated that the next generation of such sensors should be mobile, ideally imperceptible to users, as well as being capable of measuring multiple variables. Informants noted that future generations of sensors should have onboard processing, local data storage and wireless data transmission. Data collection, analysis is rudimentary and not automated It is widely assumed that telemonitoring is based on automated data streams and analysis, generating appropriate alerts for clinical staff. The interviews did not provide any evidence to support this assumption. Current telemonitoring systems rely on human judgement, guided by agreed threshold levels: when a monitored variable exceeds a limit, an alert is raised. Most studies rely on nurses at central locations to observe the data or to call patients regularly, and, if necessary, to decide on further action. Automated detection algorithms are not used for the detection of deterioration in heart failure and COPD. In chronic disease, where patients are unwell even at their best, the identification of an individual baseline and any drift away from it is essential. Informants noted that this has not been achieved so far. How to represent, analyse and respond to


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a drift from agreed individual levels is an unresolved challenge for telemonitoring systems. It was noted that the provision of feedback from sensors to patients themselves had not been considered, albeit critical to the promotion of effective selfmanagement strategies.

Identifying challenges using multi-path mapping Twenty-four individuals participated in the expert workshop [11 experts in informatics/computer science, four academic clinicians (nursing and medical), five policy advisors, two sociologists, one NHS-based consultant and one research manager]. Four groups each produced their own version of a multi-path map, annotated with a set of challenges. After the event, the maps were analysed and merged to illustrate detailed anticipated future pathways for telemonitoring (submitted for publication separately). The use of the four NPT-based questions enabled the participants to consider telemonitoring in terms of the new work and relationships generated. When merged, three major challenges to progress were identified: (1) inattention to the needs of patients and clinicians; (2) inattention to professional roles, responsibilities and organizational routines; and (3) technical hurdles. Figure 1 is a summarized version of the multi-path map illustrating the challenges identified.

Uncertain roles and accountabilities Informants reported that telemonitoring initiatives tend to be viewed as ‘bolt-on projects’ that depend on dedicated funding. This gives rise to uncertain, short-term relationships between those who are project-funded to collect and monitor patient data and those such as general practitioners who continue to work in their normal roles but who may have to respond to alerts. A key issue was the recognition that telemonitoring creates new clinical governance responsibilities and additional data management, storage and archiving. Who is accountable for the accuracy of the devices, the analysis, the alert and the response? Who is liable if an alert is overlooked or for a lack of appropriate response? Telemonitoring straddles the boundaries of many existing services (general practice, emergency, out-of-hours care and social care), and the new relationships and responsibilities generated by telemonitoring are uncharted territories.

Market embedment

First challenge: pay attention to the needs of patients and clinicians Less cumbersome sensors Clearer clinical goals for data collection

Regulatory approval

The participants noted that the push for telemonitoring comes from industry rather than from patients or clinicians. They added that devices needed to be more convenient and noted the inability

Second challenge: pay attention to professional roles and organizational routines Who carries the responsibility for responding to alerts? Is the health service willing to react to earlier detection of impending illness?

Interoperable sensors

Automated data collection

Integrated data sharing

Improved detection algorithms

Intelligent data interpretation

Improved sensor systems

Agree the data signature of impending deterioration in chronic disease

Basic research Current generation 2010

Third challenge: technical hurdles Proprietary systems need to agree interoperable standards, shared across health and social care response systems. Sensor data analysis needs to be automated and quality assured

Less burden to patients

Existing sensor systems

Product development

Inattention to the needs of patients and clinicians

Interoperable generic platform

Integration of sensor data, machine learning of individual patient baselines

Next generation

Future generation

2015

2020

Figure 1 Challenges for telemonitoring.


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of existing devices to measure variables that correlate with impending deterioration in COPD and heart failure. Clinical informants raised the possibility that sensors of movement, of activity, rather than physiological variables such as heart rate values, may be helpful indicators of deterioration, anticipating that they may be more responsive. Inattention to professional roles, responsibilities and organizational routines Participants reported a wide range of professional and organizational barriers to the adoption of telemonitoring. Health and social services are characterized by professional boundaries and procedural systems. These systems find it very difficult to be agile when innovative methods of collecting and using clinical data appear. Telemonitoring projects generate local enthusiasm and support but this is seldom incorporated into routine services. Participants mentioned that uncertainty about who bears the responsibility for the clinical response to the alert generated by telemonitoring was an important factor. Telemonitoring creates new data, new responsibilities and medico-legal accountabilities in multiple organizations. These issues have been poorly articulated and are as yet unresolved. In short, insufficient attention has been given to how telemonitoring can be integrated into existing arrangements. Technical hurdles Participants were confident that technical interoperability between devices will eventually be addressed by efforts to agree standards and will lead to the emergence of a platform approach to integrate differing data sources [25]. Participants were positive that innovations in technology may solve what seem now like intractable analytical problems. Novel techniques in interpreting data were mentioned, ‘sensemaking’ [26] and ‘machine learning’ [27], for example, that might enable automated data processing to detect impending deterioration in long-term conditions.

Discussion Principal findings When considered against an accepted understanding of monitoring, telemonitoring is found wanting: the informants included in this study did not think that telemonitoring has so far successfully managed to detect early deteriorations in patients with heart failure and COPD. The critical requirement for success would be the identification of a detectable data signature that, if identified, could yield an alert and lead to an effective and timely intervention, in other words, a clear objective that has clinical benefit. Rather than achieve this, we found that experts felt that telemonitoring has so far focused on data that are easy to collect rather than specifying data that have predictive value. There has been insufficient attention to clinical objectives and, therefore, to the specification of relevant predictor variables. Experts in the field do not consider that telemonitoring has achieved a good fit with the life world of patients nor into the professional, organizational procedures of health service delivery systems. The technologies are typically cumbersome for patients and give them new tasks to perform. Automated data transmission 900

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is rare and analysis efforts are rudimentary for detecting COPD and heart failure. Many technical hurdles prevent data integration and there is concern about data sharing across organizations. Moreover, telemonitoring technologies, and the data they deliver, create novel roles and legal accountabilities, as responses to alerts need to be safely managed. These new professional relationships span multiple organizations and care sectors and their implications have not been sufficiently considered. The collection of patient data as they live at home is being viewed as a medical transaction [28] and therefore subject to the same rules of practice [29], and a duty of care chain [30]. These challenges were reported as being unresolved. In summary, the informants interviewed stated that although there is an inherent logic in the wish to detect deterioration early in conditions such as COPD and heart failure, the translation of this objective into practical solutions requires more work.

Strengths and weaknesses of the study A strength of this work was the engagement of an interdisciplinary team spanning medicine, health care, informatics, computer science, sociology and engineering and the use of multiple research strategies (literature review, key informant interviews and a multi-path mapping workshop). These differing perspectives and multiple methods enabled the development of a wider critical gaze than would otherwise have been possible, as each discipline questioned each other’s assumptions. The participation of two sociologists enabled consideration of how technology brings with it relationship requirements that are key to its wider adoption [17]. A significant weakness is the reliance on expert accounts rather than on observations and ethnographic work in the field. We concede that the work was only undertaken in a UK context, although we consider the issues identified to be applicable in other settings.

Results in context of other work Our analysis of the research evidence resonates with other recent reviews [31,32], which confirm that cost-effectiveness has not been established for telemonitoring interventions [4–6]. The data we have collected also suggest that the anticipated use of technological sensors to diagnose deterioration in patients with long-term illness follows the classic ‘hype cycle’, where inflated expectations are followed by a trough of disillusionment [33]. High expectations are typically set up by commercial drivers. Disillusionment arrives when initial investments do not lead to the expected rewards and when the interventions do not lead to benefit in the anticipated timeframe. As others are realizing, successful telemonitoring is difficult to achieve, especially for chronic illnesses characterized by sudden exacerbations [34]. We need to contrast the reported concern about telemonitoring for COPD and heart failure with more positive reports for telecare, despite similar challenges [35]. Telecare has a simpler rationale where a response centre is alerted if a sentinel event occurs, for example, a person has fallen or if no activity is detected in a home setting. The alert signal is automated and the response is mediated by a call handler, who assesses the alert and mobilizes the appropriate response, by agreement of a range of emergency services. This response pathway is not in place for telemonitoring systems to date. Responses rely on additional clinical judgements and


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specific actions. This is an area of concern that has already been acknowledged by the UK Technology Strategy Board’s AssistedLiving road map [36] and which is being considered in the context of the Whole System Demonstrators projects [37]. Our work also revealed concerns about data transmission, safe storage and use, especially if telemonitoring data are distributed across health and social care systems. Callens and Cierkens have noted the need to be clear about the professional roles of those who handle and make decision based on these data, and whether these constitute ‘medical acts’ [38], an area already highlighted in European Directives [39]. Koch’s review of home telehealth concluded that there was a lack of evaluation frameworks that sufficiently considered legal, ethical, organizational, clinical and usability aspects alongside the technical [40]. Many of the problems identified by Koch remain unresolved. Our work confirms Cooksey’s analysis that translational gaps do exist in health research [13]. Here, the gap manifests itself in the failure to specify the predictive variables that would provide the rationale for telemonitoring and also in the lack of attention to the social use and organizational implications telemonitoring generates. May et al. pointed out these issues in earlier technology generations [41] and Lehoux has drawn attention to the failure to address the needs of both end users, namely the patient and the clinician [42]. In short, innovations that require integration between a range of actors are more likely to become embedded into practice when they attend to social and organizational as well as to technical criteria [3,43].


Acknowledgements The Grand Challenge research team at Cardiff University was composed of: Dr Omnia Allam, Dr Charlotte Bolton, Dr Ed Conley, Professor Glyn Elwyn (PI), Professor W. Alex Gray, Mr Alex Hardisty, Dr Alex Hillman, Professor Tim Maughan, Professor David Owens, Dr Susan Peirce, Professor Alun Preece, Professor Omer Rana and Dr Zaheer Yousef. The research team was joined by Dr Robert Evans, Social Sciences, Cardiff University, Douglas Robinson, MINES ParisTech (ANR-RITE Regimes de Conception) and by Professor Carl May, Newcastle University. We acknowledge the inputs we received from our informants, our focus group patients and carers, and from the experts who participated in our workshop.

Contributors G. E., A. H., A. G. and A. P. conceived the original study. G. E. was the principal investigator. G. E. and A. H. oversaw the study and S. P. and A. P. helped plan the data analysis and contributed to interpretation. All the authors contributed to the writing. All of the authors were involved in the conception, design and management, or analysis and interpretation of data; in drafting the article or revising it critically for important intellectual content and in the final approval of the version to be published. G. E. is the guarantor of the paper.

Funding Implications for research, policy, education and practice Telemonitoring, like other monitoring technologies, needs to be clear about the intended use of the data. If the aim is to detect drift from agreed limits, then the means to do that for, for example, COPD and heart failure, require agreement. These agreements do not yet exist [44] so that is the first task. The next tasks will be to design sensors that are acceptable to patients and to build on emerging algorithm-based analysis methods in other areas [45]. The applied nature of informatics in health care means that users (patients and clinicians) play a more influential role and at much earlier stages than for, say, pharmaceutical interventions. This speaks to the need to actively involve these end users, patients, clinicians and managers, in prototype development and use. Similarly, the challenge of embedding an early detection system into services means recognizing that new information leads to new responsibilities and, potentially, accountabilities. The same actors are implicated in both activities but we do not see evidence of their involvement in design and development. Addressing these two gaps requires a user-centred design method [46–49] despite the challenges [50]. Finally, the legal and organizational implications of collecting large volumes of data from ill patients will need to be resolved. Who will face the consequences when an alert does not lead to an appropriate response? In summary, those who wish to develop telemonitoring have to pay more attention to agreeing the central aim of early detection and, after that, engage the correct set of stakeholders in the design of safe processes.


This work was supported by the Engineering and Physical Sciences Research Council, grant number EP/F058640/1. Dr Bolton is funded by Nottingham Respiratory Biomedical Research Unit.

Ethical approval Ethical approval for the study was obtained from the South East Wales Research Ethics Committee and research and development approval was obtained from the Cardiff and Vale NHS Trust.

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