REgioNs of Europe WorkINg together for HEALTH (Grant Agreement No )

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1 ICT PSP Accessibility, Ageing and Social Integration Programme REgioNs of Europe WorkINg together for HEALTH (Grant Agreement No ) Document D3.3 Critical assessment of the test application of Version 1.0 Work Package: WP3 Version & Date: v1.0 / 4 th April 2011 Deliverable type: Distribution Status: Author: Reviewed by: Approved by: Filename: Other Public Giorgia Centis, Silvia Mancin, Claudio Saccavini John Oates Marco D'Angelantonio D3.3 v1.0 Renewing Health Critical assessment of the test application of.doc Abstract This document describes the test application of methodology to a real case in Veneto Region. This telemedicine service in support of patients with chronic diseases has been assessed following the MAST guidelines. Key Word List Telemedicine, telemonitoring, Health Technology Assessment, Model for Assessment of Telemedicine, critical assessment, chronic diseases, domains.

2 Executive Summary RENEWING HEALTH aims at implementing large-scale real-life test beds for the validation and evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology that follows HTA guidelines. A specific method has been developed for this last purpose. The new model for assessment of telemedicine (MAST) is a part of the results from project. The overall aim of is to provide a structured framework for assessing the effectiveness and contribution to quality of care of telemedicine applications. A preliminary test of the applicability of the MAST method has been carried out in Veneto Region, selecting as a real case a telemedicine application among those running in the pilot sites. This document provides a detailed description of how the MAST method has been adapted in the context of the Local Health Authority 12 Veneziana, delivering a telemonitoring service in support of patients with chronic diseases. The focus does not lie as much in the presentation of the results obtained by the application of MAST, but more in the assessment of the applicability of the method itself. Considering the results of the first MAST application, new efforts have been put into improving the adaptation of the MAST model to a real service of telemedicine. New evaluation tools following the MAST approach have been defined and are presented in this document. Overall, this report represents a useful analysis, based on a real experience that has allowed understanding of both the potential of this assessment method, but also the possible weaknesses to be addressed. The MAST application has revealed the importance of having a clear idea about how to structure the model before the evaluation starts, trying to avoid the risk of having an inappropriate tool when the pilot is already in progress. Public Page 2 of 92 v1.0 / 4th April 2011

3 Change History Version History: rd December 2010 Initial version th January th January rd February th February st March th March st March st April th April 2011 Version Changes 0.1 Initial version 0.2 Update to section Drafting of additional contents 0.4 Minor changes 0.5 Review according to Kristian Kildholm s suggestions 0.6 Review by John Oates 0.7 Other minor change 0.8 Formatting changes 0.9 Minor clarifications to questionnaires 1.0 Version for release Outstanding Issues None Public Page 3 of 92 v1.0 / 4th April 2011

4 Table of Contents EXECUTIVE SUMMARY 2 CHANGE HISTORY 3 TABLE OF CONTENTS 4 1. INTRODUCTION Purpose of this document Structure of document Glossary 7 2. APPLICATION FIELD Introduction Poli-specialistic telemedicine home care, Venetian Health Unit Usual care organisational workflow Telemonitoring organisational workflow FIRST TEST ADAPTATION OF MAST IN VENETO REGION Introduction Preceding considerations before assessment was initiated Definition and application of some MAST domains Scientific literature review Identify the relevant topics for the assessment Methods for data collection Results from the telemonitoring service evaluation Considerations on MAST applicability METHOTELEMED IMPROVEMENT AND DEVELOPMENT Further activities New domains definition LESSONS LEARNED Strengths Weaknesses outstanding issues 91 TABLE OF FIGURES Figure 1 - Usual care for patient with CVD and PM in LHA Figure 2 - Usual care for patient with COPD in LHA Figure 3 - LHA 12 telemedicine service architecture Figure 4 - Organisational workflow of telemonitoring service for patients with CVD and PM Public Page 4 of 92 v1.0 / 4th April 2011

5 Figure 5 - Organisational workflow of telemonitoring service for patients with COPD Figure 6 - Preceding considerations before starting with the evaluation Figure 7 - Results from sensitivity analysis TABLE OF TABLES Table 1 MAST Domains selected for the first test application Table 2 - Selection of topics for Domain Table 3 - Selection of topics for Domain Table 4 - Selection of cost items for economic analysis in the domain Table 5 - Selection of topics for Domain Table 6 - Selection of topics for Domain Table 7 Consumption of resources for one arterial blood gas analysis (comparison between usual care and telemedicine) Table 8 Costs of resources for one arterial blood gas analysis (comparison between usual care and telemedicine) Table 9 Patients telephone interviews: questions and answers Table 10 Detailed data of the unit cost of resources Table 11 Example of types of resources included in the estimation of costs Table 12 - Example for prices used in the calculation of costs Public Page 5 of 92 v1.0 / 4th April 2011

6 1. Introduction 1.1 Purpose of this document RENEWING HEALTH aims at implementing large-scale real-life test beds for the validation and evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology that follows HTA guidelines. A specific method has been developed for this last purpose. The new model for assessment of telemedicine (MAST) is a part of the results from project. The overall aim of is to provide a structured framework for assessing the effectiveness and contribution to quality of care of telemedicine applications. This document describes the adoption of MAST for a telemedicine service within the RENEWING HEALTH project, giving a critical overview of its applicability to a real case. Even if this document provides a summary of the results obtained from the first preliminary application, the aim is not to obtain a final HTA report with a systematic assessment of all the outcomes of the Venetian telemonitoring service, but to test the applicability of the MAST method to a real case, and hence provide useful and critical feedback about the strengths and weaknesses of the method. 1.2 Structure of document Section 2 is dedicated to the presentation of the context where the test took place. Specific information about the telemedicine service delivered by Local Health Authority 12 Veneziana can help to understand how the method was implemented and tested. Section 3 then presents the particular application of the MAST method to the Venetian real case, first describing the road that led to the definition of part of the method, listing all the MAST domains analysed starting from the study of the MAST manual and from the scientific literature review. These domains, once defined, were then applied to a telemonitoring service. A description of how the theory was put into effect is provided with both the results related to the evaluated service, and some considerations deriving from the MAST application itself. Section 4 describes the subsequent activities that have led to enhancing the initial method into a more suitable evaluation tool that is presented here. Section 5 presents the strengths and weaknesses of the method, with some still outstanding issues on its applicability. Public Page 6 of 92 v1.0 / 4th April 2011

7 1.3 Glossary ADSL ADT CMA COPD CVD CRF DALY DB DICOM DRG ECG EHR ER FEV FVC GOLD GP GPRS HIS HTML HTTP JPEG LAN LHA LIS LVEF MAST MPEG M403 NYHA PC PDA POCT PSTN Asymmetric Digital Subscriber Line Admission, Discharge and Transfer Cost-Minimisation Analysis Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Case Record Form Disability Adjusted Life Years Database Digital Imaging and COmmunications in Medicine Diagnosis Related Group Electrocardiogram Electronic Health Record Emergency Room Forced Expiratory Volume Forced Vital Capacity Global Initiative for Chronic Obstructive Lung Disease General Practitioner General Packet Radio System Hospital Information System HyperText Markup Language Hypertext Transfer Protocol Joint Photographic Experts Group Local Area Network Local Health Authority Laboratory Information System Left Ventricular Ejection Fraction Model for the Assessment of Telemedicine Moving Picture Experts Group European Commission mandate to the European Standards Organisations (ESOs) on standardisation in the field of e-health New York Heart Association Personal Computer Personal Digital Assistant Point of Care Testing Public Switched Telephone Network Public Page 7 of 92 v1.0 / 4th April 2011

8 QALY RIS UMTS VPN XML WP Quality Adjusted Life Years Radiology Information System Universal Mobile Telecommunications System Virtual Private Network extensible Markup Language Work Package Public Page 8 of 92 v1.0 / 4th April 2011

9 2. Application field 2.1 Introduction The context selected was the Local Health Authority 12 Veneziana (Veneto Region). The service considered for the evaluation is a telemonitoring solution in support of patients with chronic diseases. Several actors were involved in order to carry out a multidisciplinary analysis, taking into account some of the most important aspects characterising the telemedicine application, according to the limited timetable allowed for the assessment. Starting from the MAST manual and the related material, some MAST domains were developed; in addition, a deep literature review about telemonitoring state of the art, was done, which was helpful in the selection of the outcome measures to be included in the HTA analysis. These domains were then tested using the telemonitoring service for patients with chronic diseases (focusing on patients with COPD and cardiovascular diseases). 2.2 Poli-specialistic telemedicine home care, Venetian Health Unit 12 With telemedicine, Venetian Local Health Authority (LHA) 12 aims to provide a suitable and modern health service to patients who are located in areas as unique and peculiar as Venice historical centre, islands, and mainland. It is precisely in these first two environments where the LHA must inevitably move away from traditional patterns of management, and adapt them to the distinctive features of the territory. Here, mobility both of patients and healthcare workers is strongly reduced in comparison with the rest of Italy: the absence of cars (with the exception of two islands) makes it necessary to move on foot, by bus or, in case of emergency or need for transfer to the hospital, by boat-ambulance. The time needed, the organisational difficulties, the high costs and the considerable amount of human resources involved have induced LHA 12 to looking for alternatives to the usual follow-up care of chronic patients. A telemedicine service has therefore been conceived in order to monitor both chronic elderly patients or those with limitation in mobility, directly in their homes. The Venetian telemedicine service is addressed to patients with cardiovascular diseases (tele-cardiology), COPD (tele-pulmonology, all the patients are in oxygentherapy programme) or suffering from arterial and venous ulcers (tele-dermatology). It consists of periodical home-care visits at the patient s home performed by a nurse. The check-up is carried out through two software systems: AMBULATORIO AD: a web program that allows the nurse fills in the form with the vital statistics, clinical results, and checks of the instrument tests obtained during the home visit, and finally closes the visit. Public Page 9 of 92 v1.0 / 4th April 2011

10 AD MANAGER: a program installed on the laptop used by the nurse to perform the home visit. It allows the collection of the instrument results and tele-counselling with the medical practitioner. Patients who are not tele-monitored keep on being followed in usual care. In this case the patient has to go the hospital whenever an outpatient visit is planned. 2.3 Usual care organisational workflow The LHA 12 telemedicine service is addressed to patients with difficulties in mobility who would therefore require transport to hospital by expensive boat-ambulances. Patients without this limitation will continue going to the hospital for scheduled outpatient- follow-up. For patients with cardiovascular diseases (CVD) and a Pacemaker (PM), the usual care consists of scheduled outpatient visits at the SS. Giovanni e Paolo hospital in Venice Centre, usually twice in a year, but more frequently if the patient health conditions get worse. Patients without problems in mobility can go to the hospital on their own, whereas for patients not able to move (most of them) an authorisation for boat-ambulance transport is needed. During the outpatient visit, the cardiologist performs the ECG test, measures other patient symptoms (possible lack of breath, chest pain, etc.) and checks the PM battery status, while the nurse is just in charge of helping the physician with the instrumental tests, for example positioning the ECG leads on the patient s chest. The normal workflow for these patients is shown in Figure 1 below. Public Page 10 of 92 v1.0 / 4th April 2011

11 Figure 1 - Usual care for patient with CVD and PM in LHA 12 COPD patients have a more controlled follow-up, since they need a more subjective therapy, strictly according to their health status variations. In usual care, the lung specialist plans scheduled outpatient visits for the COPD patient at the pulmonology ward at the Ospedale dell Angelo hospital, located outside the Venetian historical centre, and, for this reason, the boat-ambulance transportation is not always required. These outpatient visits are more frequent, until once a week, and usually require an arterial blood gas analysis, as it provides a complete set of clinical parameters sufficient to describe the patient health status; also, most of the COPD patients are not able to perform a spirometry test. Also in this case, the nurse just helps the specialist with the instrumental test performance. The normal workflow for these patients is shown in Figure 2 below. Public Page 11 of 92 v1.0 / 4th April 2011

12 Figure 2 - Usual care for patient with COPD in LHA Telemonitoring organisational workflow The first MAST test was carried out in Veneto Region using the LHA 12 telemonitoring service in support of patients with cardiovascular diseases (in particular, those ones with PM) and COPD. This service is one of those running in the RENEWING HEALTH context. The evaluation methodology was developed in order to allow the comparison between telemedicine and usual care. In Venice, telemonitoring is studied to improve the follow up of chronic patients affected by COPD (included those ones with mechanical ventilation and in an oxygen therapy programme) and cardiovascular diseases. The service consists of periodic visits to patients homes, where a trained nurse goes in order to measure Public Page 12 of 92 v1.0 / 4th April 2011

13 some clinical parameters and data from patient medical history. It is delivered through five main steps: 1. The nurse books the patient visit (it could be made in advance) directly from his workstation through the web program AMBULATORIO AD, inserting all the personal and clinical data relevant for the visit. 2. Before leaving for the home visit, the nurse synchronises his/her laptop, importing all the visit-related patient data inserted by AMBULATORIO AD, through the corporate LAN of LHA 12 health district. 3. The nurse visits at the patient s home, and uses portable medical devices to collect clinical data. COPD and cardiovascular visits differ in terms of the tests performed, and consequently the clinical measurements: - CVD patients: after checking the PM battery status, the nurse performs the ECG test, connecting the leads to the laptop, where the ECG trace is displayed and the pulse rate provided. Other parameters are measured, such as chest measurement, possible lack of breath and other symptoms. - COPD patients: data collected are spirometry and oximetry through portable spirometer and pulse-oxymeter, connected to the nurse laptop. However, most of the times the patient is not able to perform a spirometry test, therefore the trained nurse examines him through arterial blood gas analysis, using a POCT device that quickly provides all test results. Arterial blood gas analysis absolutely replaces the spirometry and oxymetry test, as it provides all the necessary parameters to define the patient health status. All the collected data are automatically registered in AD MANAGER system, installed on the nurse laptop. 4. The nurse starts the second synchronisation (between the two systems, from AD MANAGER to AMBULATORIO AD) via UMTS connection directly from the patient s home. If some parameters are not in their normal range, the nurse can call the specialist to ask about what to do. 5. From his workstation in the hospital, the specialist receives telemonitoring data and closes the visit on the web with AMBULATORIO AD, realising the medical report with the information transmitted from the patient s home. Public Page 13 of 92 v1.0 / 4th April 2011

14 Figure 3 - LHA 12 telemedicine service architecture The following two diagrams describe the workflow of the two telemonitoring services considered for the MAST application. Public Page 14 of 92 v1.0 / 4th April 2011

15 Figure 4 - Organisational workflow of telemonitoring service for patients with CVD and PM Public Page 15 of 92 v1.0 / 4th April 2011

16 Figure 5 - Organisational workflow of telemonitoring service for patients with COPD Public Page 16 of 92 v1.0 / 4th April 2011

17 3. First test adaptation of MAST in Veneto Region 3.1 Introduction Starting from the MAST manual and from a scientific literature review, the first MAST test was carried out through several phases that required specific actions and involved people. Five domains were selected for the evaluation of the telemonitoring service delivered by Venetian LHA 12: Health problem and description of the application. Safety (technical safety). Economic aspects. Organisational aspects. Socio-cultural, ethical and legal aspects (ethical aspects). This chapter describes the steps that led to the definition of the domains, how these domains were analysed and developed through the selection of the issues to be deepened, and then how the defined domains were put into effect in order to collect the required information. The test results are summarised at the end of this chapter, followed by some considerations about MAST applicability. 3.2 Preceding considerations before assessment was initiated Following the MAST guidelines, before defining the assessment criteria, some consideration was given as to the best telemedicine application to recommend to allow the MAST test in Veneto Region, and which were the relevant alternatives, taking into account that the assessment is at local level. The Venetian telemonitoring service was selected from the others because it has three years experience (it was an initiative started in February 2007), and because of the knowledge of the clinical staff in the telemedicine field. The telemonitoring is addressed to chronic patients that are followed in their own homes thanks to telemedicine. The aim is to provide the patients with a better quality of care, reducing unnecessary travel to the hospital, and at the same time helping to reduce the high costs of boat-ambulance transportation from patient s home to hospital and back, and the consequent organisational problems. The alternative to telemedicine is the usual care that foresees the traditional hospital follow-up of these chronic patients. Figure 6 - Preceding considerations before starting with the evaluation Public Page 17 of 92 v1.0 / 4th April 2011

18 The second preliminary step was the identification of the people with whom to collaborate for this test application, according to their competences and level of involvement within the telemedicine service. 3.3 Definition and application of some MAST domains This preliminary test was carried out through the analysis and application of five MAST domains, leaving out those ones requiring a longer test period. For example, the test of the clinical effectiveness would need at least 12 months just for the follow-up period in addition to the months necessary for the recruitment of a significant number of patients. The tested domains are: Health problem and description of the application. This domain allows a preliminary qualitative / quantitative analysis of the service, serving as a general background description, from a clinical and technological point of view. Safety (Technical safety). These are issues related to the technical reliability of the telemedicine application, such as back-up systems, possible faults, data privacy and security, etc. Economic aspects. From the economic point of view, telemedicine can have an important impact, both for the patient and the healthcare institution. Organisational aspects. This domain considers what kind of resources have to be mobilised and organised when implementing a new application, and what kind of changes or consequences the use of telemedicine can further produce in the organisation. Socio-cultural, ethical and legal aspects (Ethical aspects). These values, moral principles and social rules (norms) form the basis of social life as well as national laws; consequently it is important to understand them. These factors play a key role in shaping the context in which telemedicine applications are used. Public Page 18 of 92 v1.0 / 4th April 2011

19 Table 1 MAST Domains selected for the first test application Domain 1 Health problem and characteristics of the Domain 2 Safety Domain 3 Clinical effectiveness Domain 4 Patient perspectives Domain 5 Economic aspects Domain 6 Organisational aspects Domain 7 Socio-cultural, ethical and legal aspects Domain Flagged if adopted in the LHA 12 study 1.1 Health problem 1.2 Description of the application 1.3 Technical characteristics 2.1 Clinical safety 2.2 Technical safety 3.1 Effects on mortality 3.2 Effects on morbidity 3.3 Physical health 3.4 Mental health 3.5 Effects on health related quality of life (HRQL) 3.6 Behavioural outcomes (e.g. exercise) 3.7 Utilization of health services 4.1 Satisfaction and acceptance 4.2 Understanding of information 4.3 Confidence (in the treatment) 4.4 Ability to use the application 4.5 Access and accessibility 4.6 Empowerment, self-efficacy 5.1 Economic evaluation (societal perspective) 5.2 Business case (institutional level) 5.3 Sensitivity analysis (Risk analysis) 6.1 Process 6.2 Structure 6.3 Culture 6.4 Management 7.1 Ethical issues 7.2 Legal issues 7.3 Social issues We did not test the domain of patient perspective, as we did not have a validated and standard questionnaire at the moment of this pre-assessment test. Also, clinical safety was not included, as we did not have a clear idea on how to interpret the concept of clinical safety, and we needed more information and suggestions to identify possible harms due to telemedicine Scientific literature review MAST manual provides several references from a scientific literature review that have led to the MAST structure definition, with the identification of the relevant outcomes measures to be taken into account for the assessment. On the basis of these references, for all domains analysed in the Venetian study, a specific and exhaustive scientific literature review was carried out before defining the outcome measures used to assess the telemedicine application. This scientific literature review allowed us to have a basic but clear idea about how a telemonitoring service works, which are the kinds of patients the service can be addressed to, which are the main technologies used, who are the people usually involved, what economic impact the telemonitoring service can have, etc. As well as providing some valuable indications in general on the Health Technology Assessment (HTA) world, the literature can suggest the main outcome measures used so far, offering some helpful examples of telemonitoring services and, at the same time, providing a sort of comparison model. Public Page 19 of 92 v1.0 / 4th April 2011

20 The following bibliographic databases were searched: PubMed, Cochrane Library. IEEE Xplore Digital Library. National Library of Medicine (for the main HTA s concepts). Centre for Reviews and Dissemination (CRD). the Agence d évaluation des technologies et des modes d intervention en santé (AETMIS). Health Technology Assessment international (HTAi) database. Canadian Agency for Drugs and Technology in Health (CADTH) database. The main keyword combinations used were: [telemonitoring or telecare or telemedicine or telehealth], and [chronic diseases or Chronic Obstructive Pulmonary Diseases or Cardiovascular disesas]. Results were limited to articles published from 1999 onwards and no language restrictions were imposed Identify the relevant topics for the assessment The first step to make the MAST model an operating tool was the identification of the relevant topics for each selected domain. As MAST suggests, topic stands for the theoretical issues about telemedicine that will be measured empirically either in qualitative and quantitative terms (outcomes measures). The scientific literature review on telemonitoring services described above just had the aim to allow an understanding of what are the most relevant aspects to be taken into account when a telemonitoring service is analysed. The results of the review guided us in the selection, among the topics proposed in the MAST manual, of those ones considered most relevant to characterise the LHA 12 reality, leaving out those ones less important and adding others considered more suitable to describe the Venetian telemonitoring service. Below, the next sections (one for each domain) show the topics selection among those proposed by the manual and those added as a consequence of the literature review Domain 1 - Health problem and description of the application This domain was developed by not thinking about the specific service it was addressed to, but rather thinking about a generic telemedicine service, in order to allow the next application of a method as similar as possible in all the RH Clusters where the Veneto Region is involved. This consideration does not apply to the first clinical part, as it deals with the specific disease and patients treated with telemedicine. The choice of this domain is due to the need to have a specific but unbiased description of the service, of the reason why it is proposed, and who it is addressed to. The domain is structured through three sections: Health problem. As this domain was conceived for testing the telemonitoring service for CVD patients, the first part includes the description of the main cardiovascular diseases, with the symptoms, the health consequences, the number of CVD patients treated by the LHA, the burden of the disease, some Public Page 20 of 92 v1.0 / 4th April 2011

21 information related to the usual care of these patients, and relations with other treatments. Description of the telemedicine application. This part deals with main characteristics of the application itself, the devices used, the kind of patients selected for using telemedicine (as they do not correspond to the entire CVD population), the life cycle of the service, and the regulatory status. Technical characteristics. From the technical side, the main features considered for analysis were the service architecture, the infrastructure and integration requirements, and the technical support. The table below compares the topics proposed by the MAST manual with those ones selected for the Venetian analysis. Table 2 - Selection of topics for Domain 1 Domain 1 Health problem and characteristics of the application Health problem Description of the application Technical characteristics Topics suggested in the Mast Manual Definition of target condition/disease Symptoms, consequences Number of patients (epidemiology) Burden of disease, resource use Current management of health condition Existing quality standards Relations to other conditions or treatments Change in patient segments Features of the application Tools required for using the application Training and information needed for utilizing the application (staff and patients) Maturity of the telemedicine application (life cycle) Division of responsibility for the technical solution between involved organisations. Regulatory status Technical platform Market situation Infrastructure requirements Interoperability Technical support Technical environment Standards User support Back-up procedures and systems Topics adopted in the LHA 12 study (flagged if adopted) Users of the telemedicine application Service architecture (covered in "Integration requirements" topic) (covered in "Integration requirements" topic) Public Page 21 of 92 v1.0 / 4th April 2011

22 From the topics proposed in the MAST manual (second column), a set of indicators was selected from those proposed in MAST for this test application (flagged in the third column). Other topics (specified in the third column) were added following the scientific literature review Domain 2 - Safety (technical safety) As the MAST manual suggests, we have interpreted the safety concept from two different perspectives, i.e. clinical and technical; but just the second one was considered for the preliminary test, as we had difficulties to interpret the concept of clinical safety. More precisely, the main doubts were around the definition of the possible harms due to the use of telemedicine. Even talking with clinicians, it was not obvious to identify dangerous conditions related to the use of telemedicine and turn the topics proposed by the manual into real use cases. More efforts will be made with a view to the next RH pilots. Talking about technical safety instead, the same considerations about the generalisation of the analysis were taken into account for this domain. Even if it was tested with the CVD telemonitoring service, the topics selected could have been used also for other services. From the technical side, the focus is on the technical reliability of the telemedicine system, including issues such as the back-up systems, the possible communication errors and failures, anti-virus software, performance tests, the influence of technical experience, the data security and privacy, as is showed in Table 3 below. Table 3 - Selection of topics for Domain 2 Domain 2 Safety Topics suggested in the Mast Manual Topics adopted in the LHA 12 study (flagged if adopted) Clinical safety Technical safety What are the direct or indirect harms when using the telemedicine application? What is the scope of the harms? What are the types of harms? Are there estimates of incidence of harms? What is the timing of onset of harms? What is the duration and severity of the harms? What can be done to minimise the harms? Is there a backup system and how does it work? What do the Service Level Agreements cover? Does the technology experience interference and what are the consequences? How is the safety compared to alternative technologies? How is security of data and the database (data privacy) and quality of data managed? Errors or failures in communication Anti-virus software Performance test Experience in using technology Privacy and data security Only technical safety was considered for the first test application. From the topics proposed in the MAST manual (second column), a set of indicators has been selected for this test application (flagged in the third column). Other topics (specified in the third column) have been added following the scientific literature review. Public Page 22 of 92 v1.0 / 4th April 2011

23 Domain 5 - Economic aspects This domain aims to describe the economic aspects related to the introduction of telemedicine in the hospital healthcare system. The analysis has been structured considering one particular telemonitoring service that implies the follow-up of patients with COPD, focusing on one particular kind of home test, such as the arterial blood gas analysis performed by a nurse directly at the patient s home. The two main economic analyses required within the MAST manual are: 1. A societal economic evaluation comparing a telemedicine application with other relevant alternatives in terms of both their costs and consequences. 2. An analysis of the expenditures and revenues for the healthcare institutions using the telemedicine application. In this study, the focus was on the first part, leaving out the business case. As suggested in the MAST manual, the societal economic evaluation should include all kinds of resources used by the hospital, the municipality, the patient and the relatives for telemedicine, since their use was expected to change after the introduction of the telemedicine application. Starting from the suggestions in the manual, a set of cost items (related to the resources used) was selected thinking about the particular LHA 12 reality, as it is showed in the table below. This required a deep knowledge about how the arterial blood gas test is delivered in the telemedicine context, in order to understand the resources used for the Venetian service; these were divided into three main categories: Healthcare provider related resources. Resources invested by the patient and his/her relatives. Resources belonging to other public institutions or voluntary work. Table 4 - Selection of cost items for economic analysis in the domain 5 Domain 5 Economic aspects Cost items suggested in the Mast Manual Cost items adopted in the LHA 12 study (flagged if adopted) Economic evaluation (societal perspective) Amounts of resources used when delivering the assessed telemedicine application Types of resources: - Investments in equiptment - Training of staff - Maintenance - Use of staff (for each of the relevant type of staff) - Medication - Utensils - Patients Use of time - Relatives Use of time - Transportation Line charges Equipment's operating costs Public Page 23 of 92 v1.0 / 4th April 2011

24 For the economic evaluation, a set of cost items (related to the resources used for the telemedicine service) was specified, starting from the MAST manual indications Domain 6 - Organisational aspects Organisational aspects are a crucial point in the evaluation of telemedicine, because the introduction of this new kind of service heavily affects the working routines or the distribution of tasks between healthcare professions for healthcare providers. Maybe the most relevant impact of telemedicine is on the organisational side, determining a close link with the other MAST domains. Considering the MAST proposal for issues to be included in the analysis, and the results of the literature review, the identified topics were subdivided into general categories: Process: all the issues related to changes in the workflow and tasks shift, staff training, interaction and collaboration. Culture: the clinical staff perception towards the telemedicine application was taken into particular account. Management: this part deals with the general responsibility of the telemonitoring service. Thinking about the Venetian service, organisation is quite specific for the two kinds of telemonitoring, for CVD and COPD patients; the main difference is the test carried out and consequently the clinical parameters monitored at the patient s home. So when defining topics (see the table below), no particular attention was paid to the kind of telemonitoring service the analysis would address. Domain 6 Organisational aspects Process Structure Culture Table 5 - Selection of topics for Domain 6 Topics adopted in the LHA Topics suggested in the Mast Manual 12 study (flagged if adopted) Workflow Changes in the workflow, task shifts Staff, training and resources Staff, training Interaction and communication Interaction and collaboration Spread of technology, centralization or decentralization Economy Attitude and culture Clinical staff perception towards telemedicine Management Management From the topics proposed in the MAST manual (second column), a set of indicators has been selected for this test application (flagged in the third column). Other topics (specified in the third column) have been added following the scientific literature review. Public Page 24 of 92 v1.0 / 4th April 2011

25 Domain 7 - Socio-cultural, ethical and legal aspects (Ethical aspects) Even if this is the last domain, ethical and legal aspects are a crucial point to be considered before starting with the assessment. Ethics is at the base of telemedicine, as it appraises questions raised by the application itself and by the consequences of implementing / not implementing it. Most of these issues are considered in a particular RH Work Package, Security, privacy and ethical issues (WP7). Even if it would have been necessary to complete some of the tasks within this Work Package to have a sufficient level of knowledge about ethical and legal aspects, the ethical section was preliminarily defined for this study. Based on the MAST proposal and on the results from literature, the topics selected are presented in Table 6 below. Table 6 - Selection of topics for Domain 7 Domain 7 Socio-cultural, ethical and legal aspects Ethical issues Legal issues Social issues Topics suggested in the Mast Manual Overall questions: Does the application challenge religious, cultural or moral beliefs? Potential ethical problems Autonomy: Is the patient s autonomy challenged or increased? Equity Clinical accreditation Information governance Professional liability Patient control consent, access Changes in the patients role in major life areas Patients relatives and others understanding of the technology Societal, political context and changes Changes in responsibility Gender issues Topics adopted in the LHA 12 study (flagged if adopted) Potential ethical issues Invasiveness of the service Doctor-patient relationship Patient's involvement Only ethical issues were considered for the first test application. From the topics proposed in the MAST manual (second column), a set of indicators has been selected for this test application (flagged in the third column). Other topics (specified in the third column) have been added following the scientific literature review Methods for data collection Once the domains were defined with all topics considered relevant for the assessment, the next step was to establish which method would be the most convenient to collect and manage the required information. Depending on whether the analysis must be qualitative or quantitative, each domain required a specific method for data collection. Public Page 25 of 92 v1.0 / 4th April 2011

26 For the domains 1,2, 6 and 7, the idea was to propose some questionnaires (one for each domain), deepening all the topics defined in the previous phase through detailed questions that are shown below, domain by domain, where the comparison between telemedicine and usual care is implicit in some of the questions. As the analysis required was both qualitative and quantitative, not all the questions were answered in the same way. Information about the service was collected involving the main reference persons working first hand with telemedicine. They answered in part thanks of their experience and knowledge about the service (qualitative information), in part after having consulted the hospital registries and databases (quantitative information). Domain 5 had to be based on a quantitative analysis that entailed a particular economic evaluation comparing the telemedicine application with the only alternative of the usual care. These domains were not tested with only one kind of patients. The aim of this test application was not to realise a final HTA report with the results of evaluation, but rather to provide a critical assessment of the applicability of MAST: the choice of alternating the analysis with different kinds of patients is for testing the generalisability of the method Domain 1 - Health problem and description of the application The first domain requires both qualitative and quantitative data, as it deals with the description of the telemedicine application itself and with some statistical information on the burden of the diseases treated and the characteristics of the particular kind of patients. All the topics identified from MAST manual and from the scientific literature review were specified in detailed questions, almost all close-ended with response categories, necessary to avoid possible bias or misinterpretation of questions by the people interviewed; at the same time, this guarantees high level evidence of responses. The comparison with the usual care is inside the questionnaire resulting from this process: most of the questions highlight the difference of telemedicine with respect to the usual care. The telemedicine service considered for the test application of this domain is the one addressed to patients with cardiovascular diseases. Below, all the questions specified are grouped according to the related numbered topics that are those shown in the tables in the previous paragraph. HEALTH PROBLEM 1. Definition of target condition/disease Cardiovascular diseases description Atherosclerosis Myocardial infarction Angina pectoris Cardiomyopathy Myocarditis Heart failure Valvular heart diseases Tachycardia Public Page 26 of 92 v1.0 / 4th April 2011

27 Vascular diseases Other 2. Symptoms, physical consequences What are the main symptoms? Dyspnea Chest pain Cyanosis Cardiac syncope Palpitation Oedema What are the secondary symptoms? Cough Hemoptysis Weakness cturia Anorexia Nausea Vomiting Fever Chills What are the physical consequences? 3. Number of patients According to NYHA classification, how many patients with cardiovascular diseases are treated (in general) by ULSS 12? Level I Level II Level III Level IV What is the prevalent gender of patients with cardiovascular diseases? M F What is the mean age? years years years years years What is the mean educational level? Primary school Middle school High school University Public Page 27 of 92 v1.0 / 4th April 2011

28 On average, how many admissions have there been for these patients in the previous year? (n admissions) On average, how many times have these patients been visited by a specialist in the previous year? (n specialist visits) On average, how many visits at ER have there been for these patients in the previous year? (n visits at ER) On average, what is the Left Ventricular Ejection Fraction (LVEF) for these patients? (LVEF) What is the mean cardiac output for these patients? (cardiac output) What is the mean level of blood pressure for these patients? (blood pressure) 4. Burden of disease, resources use What are the annual costs for disease management? (thousands of ) What is the mean mortality rate for patients with cardiovascular diseases? (Mortality rate: deaths / n patients with CVD*100) What is the mean morbidity rate for patients with cardiovascular diseases? (Morbidity rate: n CVD patients/n people under LHA 12) What is the Quality-Adjusted Life Year (QALY) index for this group of patients? (QALY index) What is the Disability-adjusted life year (DALY) index for this group of patients? (DALY index) Has the HRLQ (Health-related Quality of life) index ever been calculated for these diseases? If this index has never been calculated, why? What difficulties does the disease bring in patients everyday life? What kinds of professionals are involved? Specialists GPs Nurses Anaesthetists Pharmacists Caregivers Radiologists Nutritionists Psychologists Public Page 28 of 92 v1.0 / 4th April 2011

29 Others Which other resources are exploited? Devices Medication Transports Which particular course of action has to be followed by the patient? 5. Current management of health condition (without telemedicine) What is the first contact for the patient? Which departments are involved? Which examinations/tests / intervention are scheduled? Electrocardiography Electrocardiography Holter Ultrasonography Venous doppler Arterial doppler Chest X-ray Cardiac stress test Cardiac CT Cardiac scintigraphy Cardiac magnetic resonance Monitoring of blood pressure Cardiac catheterisation Coronary angiography PM implantation Which devices are used? Devices for ECG with leads Blood pressure meter Glucometer Pulse-oximeter Thermometer Weight scale Which medication is prescribed? Beta blockers Calcium channel blockers Cardiac glycosides Diuretics Antiarrhythmic agents 6. Relations to other treatments Map all departments involved in the usual therapeutic path of the patient (with the relations between these). Which other specialists (in addition to cardiologists) treat the patient? Neurosurgeon Nutritionist Public Page 29 of 92 v1.0 / 4th April 2011

30 Radiologist Rheumatologist Psychologist Others DESCRIPTION OF THE TELEMEDICINE APPLICATION 7. Features of the application Type of telemedicine service Telemonitoring Tele-counselling Tele-laboratory Tele-assistance Integration of more services (specify which ones) Is telemedicine only a home service?, also hospital-based. Actors involved: Specialists Which ones? How many are there? GPs How many are there? Nurses How many are there? Are the same nurses always involved? Pharmacists How many are there? System administrators Who are they? Local Health Authorities Which ones? Specific health institutions Which ones? Computer scientists How many are there? Psychologists How many are there? Caregivers How many are there? Patients Relatives s Are there any other specialists to be involved to make the service optimal? If yes, who? Public Page 30 of 92 v1.0 / 4th April 2011

31 Are the actors involved in the telemedicine service the same as those involved in the current hospital service? If not, which actors are involved only in the hospital service? Specialists GPs Nurses Pharmacists System administrators Local Health Authorities Specific health institutions Computer scientists Psychologists Caregivers Relatives s Is the telemedicine service synchronous or asynchronous? Synchronous Asynchronous What are the main steps to deliver the telemedicine service? What are the main steps for the corresponding hospital service? Who is in charge of managing the patient appointment schedule? Specialists GPs Nurses s Do the waiting times usually get reduced compared to normal hospital practice?, they get extended, they are the same Is telemedicine a regular service?, it is delivered depending on patient health conditions In the second case, what are these particular conditions? Who decides when a patient can use the service? Specialists GPs Nurses s Which areas are provided with the telemedicine service? Are there particular reasons? What LHA territory percentage do these areas correspond to? Public Page 31 of 92 v1.0 / 4th April 2011

32 8. Tools required to use the application Which kinds of devices are used for the telemedicine application? Computer Web cam Microphone Telephone Modem Sensor-connected devices for wireless communication PDA Devices for ECG with leads Blood pressure meter Glucometer Pulse-oximeter Thermometer Weight scale Are the devices portable? Who uses them? Patient Physician Nurse s Are the same devices used for the normal hospital service? If not, which tools are used only for the hospital-based service (and not for the telemedicine one)? Computer Web cam Microphone Telephone Modem Sensor-connected devices for wireless communication PDA Devices for ECG with leads Blood pressure meter Glucometer Pulse-oximeter Thermometer Weight scale Which parameters are measured with the telemedicine service? ECG Blood pressure Pulse rate Temperature Oxygenation Glycemia Public Page 32 of 92 v1.0 / 4th April 2011

33 Lifestyle (mobility, falls, diet, etc.) Other What other patient data are collected? Personal data Medical history Are these the same as for the corresponding hospital service? If not, which data are collected only in the hospital case? ECG Blood pressure Pulse rate Temperature Oxygenation Glycemia Lifestyle (mobility, falls, diet, etc.) 9. Users of the telemedicine application What are the inclusion / exclusion criteria for the telemedicine service? What is the prevalent gender among patients using telemedicine? M F What is the mean age of patients using telemedicine? years years years years years On average, how many admissions have there been for these patients in the previous year? (n admissions) On average, how many times have these patients been visited by a specialist in the previous year? (n specialist visits) On average, how many visits to ER have there been for these patients in the previous year? (n visits at ER) Which diseases do these patients suffer from? Atherosclerosis Myocardial infarction Angina pectoris Cardiomyopathy Myocarditis Heart failure Valvular heart diseases Pericarditis Public Page 33 of 92 v1.0 / 4th April 2011

34 Tachycardia Vascular diseases Congenital heart diseases Heart cancer Other Why have these diseases been chosen? On average, which is the LVEF for these patients? (n LVEF) What is the mean cardiac output for these patients? (n cardiac output) What is the mean level of blood pressure for these patients? (n blood pressure) What are the tasks for each healthcare professional involved in the telemedicine service? Specialists GPs Nurses Pharmacists System administrators Computer scientists s What are the tasks for each healthcare professional in the corresponding hospital service? Specialists GPs Nurses Pharmacists System administrators Computer scientists s 10. Lifecycle of the telemedicine application Has the telemedicine application been tested before it becomes regular practice? If not, why? If yes, when did it get started? What kinds of trials have been carried out? Has a market analysis been conducted before testing the telemedicine application? If not, why? How long did it take to activate the new telemedicine programme? Public Page 34 of 92 v1.0 / 4th April 2011

35 What resources were used? Equipment Software Technical staff How have the healthcare professionals been involved? Specialists GPs Nurses Pharmacists System administrators Computer scientists s Which providers have collaborated? Was a logistic plan defined before service activation? Is the telemedicine monitored during its lifetime? How long before the telemedicine application is a regular practice? Has the telemedicine service been delivered without interruptions since it is activated? If not, why was it interrupted? Has the service had some variations during its lifecycle? If yes, why? Is it probable that the telemedicine service will be extended to a larger group of patients? If yes, considering the service characterisation, what are the barriers / benefits for its wider deployment? What additional resources would be needed? Economic resources Quantify More health professionals Specialists GPs Nurses Pharmacists Caregivers Radiologists Nutritionists Public Page 35 of 92 v1.0 / 4th April 2011

36 Psychologists s A different kind of software What features are lacking? Specific authorisation Other 11. Regulatory status Is the telemedicine service recognised within the National Healthcare System (as a DRG rate)? Are there specific laws regulating the telemedicine service? If yes, which are these laws? Are there any regulations for sharing patient personal / clinical data within the telemedicine service? Are the standards ISO9000/ISO9001 considered for the quality management of the telemedicine service? If not, are other standards / regulations considered for this purpose? TECHNICAL CHARACTERISTICS 12. Service architecture What is the service architecture composed of? Devices PC at patient home Interface (that is the connection between device and PC) PC at the hospital How do these components interact? What is the traditional hospital service architecture composed of? Devices Specialist s PC Interface (that is the connection between device and PC) How do these last components interact? Which kind of architecture is the telemedicine network characterised by? Client-server Between the PC downloading data from devices and server/pc in the hospital Public Page 36 of 92 v1.0 / 4th April 2011

37 Between device and server/pc in the hospital Peer-to-peer Which kind of architecture is the traditional service network characterised by? Client-server (between device and server/pc in the hospital) Peer-to-peer Which kind of gateway is used for the telemedicine service? Smart modem Router Internet key Personal Computer Mobile phone PDA Set-Top-Box (decoder) How does data transmission work for the telemedicine service? Data are automatically transmitted to the gateway Data are manually inserted through the user interface? Is there a preliminary automatic data processing? If yes, at which level? Server Gateway Personal device If yes, in case of error in data enter, does the system give error messages? 13. Infrastructure requirements Which are the hardware components for the telemedicine service? Screen Keyboard Cables External hard disk drive CD player Burners Printer Modem Scanner Which operating system is used? Windows Linux Mac OS X Public Page 37 of 92 v1.0 / 4th April 2011

38 Is it the same in all the PCs used? Which software applications are used? Which users can access the system? Specialists GPs Nurses Patients System administrators s How is the software user interface structured? Specialist interface (if present) Nurse interface (if present) Patient interface (if present) System administrator interface What are the features for each user interface? Specialist interface (if present) Nurse interface (if present) Patient interface (if present) System administrator interface Can the software application be defined user friendly? Are these software components realised just for this telemedicine application?, they come from another application In the second case, which application? What are the hardware components for the traditional hospital service? Screen Keyboard Cables External hard disk drive CD player Burners Printer Modem Scanner What are the software components for the traditional hospital service? Which operating system is used? Windows Linux Mac OS X Is it the same in all the PCs used? Public Page 38 of 92 v1.0 / 4th April 2011

39 Which software applications are used? What are the features for each of these software applications? Is the telemedicine software application the same as the one used in the traditional hospital service? If not, why? Which infrastructure is used for the sensors / gateway communication? Wireless Bluetooth/infrared Cable (Ethernet, USB, etc.) Which infrastructure is used for the patient home / hospital communication? Internet ADSL Internet Wi-Fi LAN GPRS/UMTS Conventional telephone network With this communication network, if the volume of data transmitted is relevant, can the system be slackened? 14. Integration requirements Which Health Information Systems (HIS) is the telemedicine system interoperable with? Health districts How is the integration? Hospital How is the integration? GP How is the integration? Laboratory How is the integration? Nursing home How is the integration? Which HIS sub-systems does the telemedicine system communicate with? Central register of the Local Health Authority How is the integration? Central register of the hospital How is the integration? Booking office How is the integration? Medical repository How is the integration? Admission, Discharge, and Transfer system How is the integration? Public Page 39 of 92 v1.0 / 4th April 2011

40 Radiology Information System How is the integration? Electronic Health Record of GP How is the integration? Other Which Health Information Systems (HIS) is the hospital system inter-operable with? Health districts How is the integration? Hospital How is the integration? GP How is the integration? Laboratory How is the integration? Nursing home How is the integration? Which HIS sub-systems does the telemedicine system communicate with? Central register of the Local Health Authority How is the integration? Central register of the hospital How is the integration? Booking office How is the integration? Medical repository How is the integration? Admission, Discharge, and Transfer system How is the integration? Radiology Information System How is the integration? Electronic Health Record of GP How is the integration? Taking into consideration the telemedicine system, which standards are used for documents sharing? HL7 HTML (HyperText Markup Language) XML (extensible Markup Language) PDF TXT DICOM for images JPEG for images MPEG Taking into consideration the usual hospital service, which standards are used for documents sharing? HL7 HTML (HyperText Markup Language) XML (extensible Markup Language) PDF Public Page 40 of 92 v1.0 / 4th April 2011

41 TXT DICOM for images JPEG for images MPEG Other Taking into consideration the telemedicine system, which standards are used for data communication? HTTP (Hypertext Transfer Protocol) HTTPs (Hypertext Transfer Protocol over Secure Socket Layer) RTP (Real-time Transport Protocol) FTP (File Transfer Protocol) SFTP (SSH File Transfer Protocol) UDP (User Datagram Protocol) Taking into consideration the usual hospital service, which standards are used for data communication? HTTP (Hypertext Transfer Protocol) HTTPs (Hypertext Transfer Protocol over Secure Socket Layer) RTP (Real-time Transport Protocol) FTP (File Transfer Protocol) SFTP (SSH File Transfer Protocol) UDP (User Datagram Protocol) Taking into consideration the telemedicine system, which standards are used for device/hospital integration? ISO/IEEE 1073 HL7 15. Technical support Does the patient interact directly with technology? If not, why? If yes, what is his technical support? Qualified staff Website Handbook What is the technical support for the healthcare professionals using the telemedicine technology? Qualified staff Website Handbook Some of the clinical and telemedicine-related questions (printed format) were addressed to a specialist and some others to a specialised nurse, both working first hand with the telemedicine application. Other items found the answer in the scientific literature. For the technical section, a computer scientist, working for the Public Page 41 of 92 v1.0 / 4th April 2011

42 LHA 12, was interviewed. People involved in this analysis have sufficient knowledge about telemedicine to be able to interpret correctly most of the questions proposed, also thanks to the structure with closed-ended questions with response categories, and answer without particular problems, except some questions related to epidemiological data, requiring maybe a more detailed survey outside the LHA databases Domain 2 Safety (technical safety) The same route was followed for the second domain, since a qualitative analysis was needed. The same service addressed to patients with cardiovascular diseases was considered for the test. Most of the questions were addressed to the same nurse that is in charge of coordinating the service from the operational point of view, as he is particularly expert on the telemedicine / technology front. Also, the LHA 12 computer scientist was interviewed for the most technical questions, as he is in charge of the maintenance of the telemedicine software adopted. TECHNICAL SAFETY 1. Back-up systems For the telemedicine service, are there back-up systems / procedures? If yes, how do they work? Who is responsible for them? Medical specialist Nurse Computer technician System administrator Is their execution automatic? How often? Are periodic checks of the system foreseen? If yes, who is responsible for them? Computer technician System administrator How often? Has it ever been necessary to use data recovery procedures since the telemedicine service was activated? Public Page 42 of 92 v1.0 / 4th April 2011

43 2. Errors or failures in communication Is there a predetermined range within which the values acquired during the home visit must lie? Are error messages provided in the case of wrong data entry? If yes, who receives them? Medical specialist from his interface Nurse who performs the visit s How can an error be fixed? If there is a failure, are other means of communication with the hospital provided? If yes, which ones? Has it ever been necessary to use these means since the telemedicine service was activated? Do the devices in the patient s home work offline? 3. Anti-virus software Is anti-virus software used? If yes, which ones? Do they slow the system? 4. Performance test Is the software subject to performance tests? Is the connection subject to performance tests? If yes, how are they performed? Are the devices subject to performance tests? Public Page 43 of 92 v1.0 / 4th April 2011

44 If yes, how are they performed? 5. Experience in using technology Does the subject s technological proficiency interfere with the correct operation of the system? What are the effects of poor technological proficiency? 6. Privacy and data security Is any encryption software deployed? If yes, how do they work? Is a digital signature used in the telemedicine service? If yes, what s the algorithm used? Did problems with these systems ever occur? If yes, which ones? As far as the usual care is concerned, is a digital signature used? If yes, what is the algorithm used? Did problems with these systems ever occur? If yes, which ones? Where are telemedicine data of the patient stored? How are the patients data in home care entered into the DB? Is the LHA s data used? Who can access the DB? Medical specialists What data can they view? What data can they use? Nurses What data can they view? What data can they use? System administrators What data can they view? What data can they use? Public Page 44 of 92 v1.0 / 4th April 2011

45 Patients What data can they view? What data can they use? Other medical specialists What data can they view? What data can they use? Is an identification system used? If yes, with what credentials? Weak (password and userid assigned online) Medium (password and userid assigned offline by the administration) Strong (need to have a PC with smart card reader and the pin code of the smart card used) It yes, how often are these credentials changed? Is the identification system identical for all of the users having access to the data?, there are different levels of protection Is there an administrator allowed to edit the patients data? If yes, who is he/she? Medical specialist Nurse Patient LHA s computer staff May the data be edited after the home visit? If yes, how? Who can do that? Medical specialist Nurse Patient s Is the identification process equal to that used to access the system? What the most frequent reason why the data are edited? Is there the belief that the solution adopted is the best available? If no, what factors impeded the adoption of the best solution? Public Page 45 of 92 v1.0 / 4th April 2011

46 Is the data safety higher, when compared to the programs used in usual care? Is any operational support manual for these procedures foreseen? Domain 5 Economic aspects A different kind of analysis is required for domain 5, dealing with the economic aspects of telemedicine. A quantitative analysis was needed, which required specific economic evaluation. As noted above, the telemedicine service considered for the telemedicine part is the execution of arterial blood gas analysis by a trained nurse at the homes of COPD patients, whereas usual care stands for the traditional way to perform the same analysis, at the corresponding hospital department. The main steps leading to the definition of the economic analysis were: 1. Adopting a specific evaluation method. For the scope of this study, the cost minimisation analysis (CMA) was chosen, based on the hypothesis that the clinical outcomes of the two treatments compared (arterial blood gas test in telemonitoring setting, and usual care) were identical. In practice, this approach was forced, because: - In the literature search, we did not find any evidence to the contrary. - It was not possible to carry out, in this limited time span, a rigorous clinical trial that could provide evidence on the clinical effectiveness of the application, necessary to perform a more complete cost-effectiveness analysis. 2. Following MAST, a societal perspective was chosen. The starting hypothesis (confirmed at the end of the test) was that the telemedicine application could give rise to probable important savings as far as patients resources are concerned. 3. Having identified all the types of resources used, assigning each of them a unit cost or price. Obviously, both investments and running costs were included. Data have been collected at two levels: group level; patient level; with methods depending on the nature of the information needed: interview with the staff; interview with the patients; reports written by the staff. Three people were interviewed among the staff of LHA 12 Veneziana: the person in charge of the Pneumology Unit of the hospital, the person in charge of the telemedicine application, and an accountant. The collaboration of the LHA s staff was fundamental, since most of the data and contacts necessary for the analysis usually come from them. Five patients, randomly selected among the application users, were interviewed by phone. They were all residents in the historical city centre of Venice, and all affected by COPD. Public Page 46 of 92 v1.0 / 4th April 2011

47 One critical aspect of interviewing the patients was obtaining their names and telephone numbers; this was a consequence of privacy issues with the LHA. Moreover, some of them, once contacted, were reluctant to contribute to the study, revealing sensitive information, even if anonymity was guaranteed Domain 6 Organisational aspects Among the methods proposed from the MAST manual, a qualitative method was selected for organisational data collection. The organisational domain was structured in a questionnaire that would be feasible for a telemedicine service in general. For this test, the telemonitoring service for cardiovascular patients was considered. The questionnaire was given to the same people, who were the most informed about the service; in this case, though, they were asked about the organisational consequences arising from the introduction of telemedicine services. The questions were only addressed to collect information about telemedicine; the same questionnaire was not used to analyse the alternative (usual care), since the comparison between them is explicit in most of the questions. The complete form for the organisational aspects questionnaire follows below. PROCESS 1. Changes in the workflow, tasks shift Once the telemedicine service is working, what are the medical specialist s new tasks? Realising the medical report Second opinion for the nurse Second opinion for the GP Second opinion for another specialist involved in the patient care process Telephone assistance to the patient Reading of monitored data Direct management of emergencies Outpatient visit Does the reorganisation of the tasks give the medical specialist a saving of time compared to the usual care? If yes, is the medical specialist able to take care of a greater number of patients thanks to the telemedicine service? Once the telemedicine service is working, what are the nurse s new tasks? Telephone assistance to the patient Measuring clinical parameters at the patient s home Reading and filtering of monitored data Direct management of emergencies Provide the patient with the instructions on how using the telemonitoring kit Interface between patient and specialist Outpatient visit Public Page 47 of 92 v1.0 / 4th April 2011

48 Who are other actors changing their tasks compared to the usual care? GPs Pharmacists Systems administrators Local Health Authorities Specific health institutions Computer technicians/health technologists Psychologists Caregivers How long does the telemedicine service delivery take? Less than 15 minutes minutes 30 minutes 1 hour more than 1 hour Overall, does the telemedicine service save time compared to the usual care?, it takes less time than usual care, it takes the same time, it takes more time than usual care Is it possible to manage more patients in one day thanks to telemedicine?, it is the same number of patients, fewer patients are treated in one day, more patients are treated in one day Regardless of the role of the patient (active or passive), is there any saving of time thanks to the telemedicine service, compared to the usual care? Is a computerised mediation centre (i.e. call centre) linking the patient and the medical specialist provided? If not, has the medical specialist an excessive data inflow? If yes, how does the medical specialist deal with this excessive data inflow? A specialised nurse is in charge of filtering data transmitted from the patient s home There is not an excessive data inflow, so he can personally check data transmitted He personally checks data transmitted, spending a lot of time Data are automatically filtered by the telemedicine software application, so only alerts and alarms are transmitted to the specialist 2. Staff, training Does the number of nurses involved vary compared with the usual care?, it increases, it decreases Public Page 48 of 92 v1.0 / 4th April 2011

49 Does the number of medical specialists involved vary compared with the usual care?, it increases, it decreases What kind of new professionals have been involved in the telemedicine process, compared with usual care? GPs Pharmacists Psychologists Radiologists s Is a training programme foreseen in order to allow the health workers to use the telemedicine service? Who, precisely, is this training addressed to? Medical specialists GPs Nurses How long did the training take? 1-3 months 3-6 months periodically, from the start of the service 3. Interaction and collaboration Does the telemedicine service ensure a higher degree of collaboration between nurses and medical specialists? Is the confidence relationship between nurses and medical specialists deepened by the introduction of the telemedicine service? If yes, does this optimise the duration of the medical care?, it does not change, it lasts longer Do the nurses have a greater degree of autonomy? Who interacts directly with the patient in the context of the telemedicine service? Medical specialist GP Nurse Public Page 49 of 92 v1.0 / 4th April 2011

50 Considering the usual care, who interacts directly with the patient? Medical specialist GP Nurse Is the communication with the patient enhanced by the telemedicine service? Who informs the patient on the telemedicine service? Medical specialist GP Nurse Relatives Does the telemedicine service contribute to patient empowerment? (Does the patient have more responsibility in his treatment?) Does the patient have the same responsibility in the usual care? For the telemedicine service, is there collaboration with the patient s relatives / caregivers?, there is no collaboration, they help the patient to collect clinical parameters, they help the patient to transmit data collected, they take care of the patient s compliance with the drug treatment, they communicate with the physician Considering the usual care, is there collaboration with the patient s relative / caregivers?, there is no collaboration, they take the patient to the hospital for periodic visits, they take care of the patient s compliance with the drug treatment, they communicate with the physician What other collaborations are there in the context of the telemedicine service? GP Pharmacist Administrative staff Psychologist CULTURE 4. Clinical staff perception towards telemedicine In general, are medical specialists satisfied with the new telemedicine service? Public Page 50 of 92 v1.0 / 4th April 2011

51 In general, are nurses satisfied with the new telemedicine service? In general, are the other professionals involved satisfied with the new telemedicine service? If not, who is not completely satisfied? Medical specialist GP Nurse Are health workers incentivised to use the telemedicine service?, all the health workers are incentivised, the specialists are incentivised, the nurses are incentivised, the GPs are incentivised MANAGEMENT 5. Management Who can be considered responsible for the telemedicine service as a whole? Local Health Authority Region s Who can make amendments to the application? Domain 7 - Socio-cultural, ethical and legal aspects (Ethical aspects) The ethical issues were summarised in a very simple questionnaire. Since this domain includes items related to very basic ethical principles, it was not necessary to involve any expert in ethical matter to answer the questions, but simply one of the persons that works first hand with the telemedicine application. Also, the nurse in charge of the compilation of the questionnaire did not have any problem with the interpretation of the questions that were generic and not addressed to a particular CVD or COPD telemonitoring service. Below the ethical questions are shown. ETHICAL ISSUES 1. Potential ethical issues Given their peculiar physical conditions, is it really problematic for the patients to go to the hospital to be seen? It depends If yes, does the telemedicine service meet the needs of the targeted patients? Public Page 51 of 92 v1.0 / 4th April 2011

52 If yes, does the telemedicine service ensure an adequate and punctual access to treatment? Why not limiting the telemedicine service to the actual emergency cases? Does the telemedicine service ensure continuity of care from the hospital to the home of the patient? Does the patient have a greater degree of autonomy thanks to this service, compared to usual care? 2. Invasiveness of the service How does the service influence the patient s daily routine, since it invades his home privacy? Is patient s domicile suitable to host a visit that would normally take place in the hospital? If not, how can the domicile be made suitable? 3. Patient s involvement Can the patient express his choice to continue with the usual care? If not, why? How was the patient convinced to take part in the telemedicine programme? 4. Doctor-patient relationship Does a confidence relationship between the doctor and the patient using the telemedicine service already exist? If not, does this produce negative effects on the continuation of treatment? In the telemedicine service, is the patient monitored by the same doctor who used to monitor him/her in usual care? If not, why? Public Page 52 of 92 v1.0 / 4th April 2011

53 5. Equity among patients Given equal pathological conditions, can all the patients use the telemedicine service? If not, why? Social status Place of residence Income 3.4 Results from the telemonitoring service evaluation In this section, results from the evaluation are presented domain by domain. All the information collected through the questionnaires is summarised and grouped according to the related topic Domain 1 - Health problem and description of the application HEALTH PROBLEM 1. Definition of target condition / disease Cardiovascular diseases are the leading cause of death in the world, accounting for the 29% of total global deaths (2004 World Health Organisation data). Of the total of 17.1 millions, 7.2 millions are due to coronary artery diseases, and 5.7 millions to stroke. Cardiovascular diseases include: Coronary artery diseases: - Arteriosclerosis: chronic inflammatory disease representing the first cause of death in western countries. - Acute myocardial infarction: acute coronary syndrome, due to a reduction of coronary blood flow in a certain area of the myocardium. - Angina pectoris: clinical syndrome due to myocardial ischemia, caused by a transient decrease in blood flow through the coronary arteries. Diseases of the heart s muscle: - Cardiomyopathy: any structural or functional abnormality of the ventricular myocardium that determines hypertrophy or dilation of ventricular chambers. - Myocarditis: progressive deterioration of the myocardium, due to physical, chemical or biological factors that lead to local inflammation, with lymphroctic infiltrate. - Heart failure: symptomatic myocardial dysfunction that makes the heart unable to supply adequate quantities of blood to the body. Valvular heart diseases: - Valvular diseases: abnormalities that may be both congenital and caused by the four heart valves. They are divided into stenosis and insufficiencies. Public Page 53 of 92 v1.0 / 4th April 2011

54 Diseases of the cardiac conduction: - Arrhythmias: a heart s electrical conduction defect, leading to an increase in heart rate (tachycardia) or its reduction (bradycardia) compared to the norm. Vascular Diseases: - Aneurysm: localised dilatation of a blood vessel, particularly of the aorta or of a peripheral artery, caused by an abnormality of the vessel wall. - Hypertension: increase of stable characteristics of blood pressure in the systemic circulation. - Thrombosis: localised intravascular coagulation. - Myocardial ischemia: hypoxia, primarily due to an obstruction leading to a decrease in myocardial blood flow. - Pulmonary hypertension: pathological condition in which the mean pulmonary artery pressure rises above 25 mmhg. - Pulmonary embolism: a complication that occurs when thrombotic is detached from the wall and migrates along the vessel. 2. Symptoms, physical consequences The symptoms of cardiovascular diseases are usually shortness of breath, chest pain, cardiac syncope, palpitation, oedema, cough, fatigue, nocturia, vomiting, fever, and chills. On a physical level, the consequences are highly disabling. 3. Number of patients In general, cardiac patients followed by the LHA 12 are not stratified according to the NYHA scale. They are mostly women with a mean age ranging from 60 to 75 years and an average level of education corresponding to upper secondary school. Last year, on average: Total hospitalisations were 150. Specialist visits - 3 per patient. 2 ER admissions per patient. LVEF is 40%. The other values requested by the questionnaire were not calculated. 4. Burden of the disease, resources use Heart diseases usually have a strong impact both on an economic and social level. This justifies the extensive use of resources in order to control and mitigate the effects of the disease: personal transport to the hospitals and back, medical devices and pharmaceuticals. This leads to a total expenditure of 10,000 per year. The disease brings with it various inconveniences in the life of the patient: lack of autonomy, inability to work, loss of dignity and impoverishment. 5. Current management of health condition (without telemedicine) In usual care, the first contact with the patient is with the medical specialist (usually a cardiologist) who makes an initial diagnosis. Cardiovascular diseases involve different departments, so there is no standard course of treatment. Normally, the last department to be involved in chronological order is the general practice that Public Page 54 of 92 v1.0 / 4th April 2011

55 begins to follow the patient once his conditions are stable. The following step is the hospital discharge and the follow-up of the patient. Different types of examinations / operations can be performed: electrocardiogram (Holter and normal), ultrasound, Doppler (venous and arterial), chest radiograph, exercise testing, cardiac scintigraphy, cardiac MRI, monitoring of blood pressure, cardiac catheterisation, coronary angiography, angioplasty, blood collection, control of the pacemaker. Other devices might be used: instruments to measure blood pressure (sphygmomanometer and cuff), the electrocardiograph, ultrasound (heart), stethoscope, blood glucose meter, pulse oxymeter, thermometer. Prescribed drugs are usually beta-blockers, calcium channel blockers, digitalis, vasodilators, diuretics, heparin, nitroglycerin and antibiotics. 6. Relations to other treatments Heart diseases require a certain degree of cooperation within multiple departments. The other specialists who may be involved, in addition to cardiologists, are nutritionists, haematologists, radiologists, rheumatologists, geriatricians, physiatrists, paediatricians, psychiatrists and oncologists. DESCRIPTION OF THE APPLICATION 7. Features of the application The telemedicine service is classified as remote monitoring, since it is delivered through periodic home visits where a nurse measures instrumental data and sends them to a specialist at the hospital. The actors involved are cardiologists, nurses, patients and their relatives and/or caregivers. There is no collaboration with GPs. More precisely, the service involves: Three medical specialists: they autonomously decide whether or not to join the telemedicine programme. 18 nurses: the ones specialised in home care. Two administrators: Telemedicina Rizzoli for the software and a nurse as coordinator for home care in the Venice area. A computer scientist, among those responsible for the system maintenance. 171 patients. According to those interviewed, the service lacks a professional with technical skills, and a technician with nursing skills at the same time. The visit takes place in synchronous mode and is organised into five main steps: 1. The nurse books the visit with the web application AMBULATORIO AD. 2. Before leaving for the patient s home, the nurse starts the synchronisation process that allows importing all the personal and clinical patient data from web program AMBULATORIO AD to AD MANAGER, used for clinical data collection. 3. The nurse completes the visit at the patient s home, using a laptop where the program AD MANAGER is installed. This program can acquire clinical patient data from the medical devices. Public Page 55 of 92 v1.0 / 4th April 2011

56 4. The nurse starts the new synchronisation of data from AD MANAGER to AMBULATORIO AD using a UMTS connection. Thanks to this operation, data collected during the home visit are sent to the LHA 12 server that makes them available to the specialist. 5. The specialist closes the visit on the web AMBULATORIO AD interface realising the final medical report. The nurse for home visits usually manages the calendar of appointments. In usual care, outpatient visits require, most of the times, patient transportation to the hospital by boat, and once the visit is over, transportation back to his/her home. 8. Tools required to use the application During a home visit, the nurse uses portable medical devices such as laptop, web cam, headset, telephone, internet key (as a modem device for ECG, while the electrocardiograph itself is replaced by software installed on the laptop). This differs from the usual care case, where electrocardiography, echocardiography, devices for measuring blood pressure and pulse oximeter are used. ECG and heart rate are monitored also with the PM battery status. 9. Users of the telemedicine application Both patients and health professionals can be considered users of the telemedicine application. The inclusion criteria for patients using telemedicine are diagnosis of cardiomyopathy or heart failure or arrhythmias, limitation in mobility and two hospital admissions in the previous year. These patients are mostly women, with an average age between 60 and 75 years. Each professional involved in the programme plays a specific role: Medical expert: he is in charge of the final report of the home visit. Nurses: in addition to managing bookings, they collect and transmit clinical data from the patient s home. System Administrator: - Coordinator of the service: is interested in the technical organisation, management and training. - Telemedicine Rizzoli: software vendor that provides initial support for all procedures and training. TMR is responsible for system configuration and arrangement of the LAN accesses. Computer scientist: supports the medical staff if some problems occur. Compared with the usual care, the main differences lie in the change in responsibilities between specialist and nurses. The cardiologist is usually in charge of the diagnosis, data collection, proposing the appropriate treatment to the patient. The nurse helps the specialist during the visit, positioning the equipment for the tests. 10. Life cycle of the application The service implementation was preceded by a phase of experimentation that began in February At that time, a technical and scientific committee was set Public Page 56 of 92 v1.0 / 4th April 2011

57 up, including head physicians of cardiology, pulmonology and dermatology, nurses, and some reference persons from the Quality and Accreditation section. An interhealth district team for telemedicine was subsequently established. Telemedicina Rizzoli provided training support for the nurses and specialists involved. Since the service was active (2007), it has had frequent changes, mostly in line with normal technological progress, which allows implementing additional functionality, such as surgery tele-consulting. It was planned to increase the number of patients using the service, regardless of the fact that the GPs do not take part in the programme and there is a general lack of education on telemedicine. On the other hand, the advantages would be clinically, but also economically, significant. It would be necessary to: purchase new instrumentation; implement software that can automatically process the data, calculate statistics and analyse the volumes of activity; involve a greater number of nurses. 11. Regulatory status The telemedicine service is not recognised by the national health system, nor is it associated with any DRG rate. The telemedicine application respects the privacy law for personal data sharing and condition of the patients. For the quality management system, the Vision 2000 series of the ISO9001 standards family are respected. TECHNICAL FEATURES 12. Service Architecture The general architecture of the telemedicine system consists of devices and a PC placed in the patient s home, interface (the link between devices and PC) and the hospital PC. These interact through the interfacing (clinical data acquisition connecting the devices with the nurse laptop) and synchronisation (transmission of collected data from one location to another) operations. Synchronisation includes both the transmission of data when the visit is booked from the web application to the nurse laptop, and the transmission of clinical data collected during the home visit to the hospital's central server. The usual hospital service differs in this sense, since the visit takes place in the outpatient clinic without using the laptop to collect data. Data are simply obtained from the device and manually inserted by the specialist or wired connecting the device to the PC. Both telemedicine and outpatient service are based on client-server architecture; the difference is that in the first case the communication is established between the nurse laptop, that downloads data from the device, and the hospital server, while in the second it is between hospital PC and server. The laptop is used as gateway that is connected to the network through Internet Key (Onda MT505UP Modem). There is no automatic data processing, and then there are no error messages if inserted data are not in the established range. Public Page 57 of 92 v1.0 / 4th April 2011

58 13. Infrastructure requirements Hardware components are monitors, keyboards, mouse, cables for connecting laptop and devices, printers and modems (internet key) for the connection. The only differences with usual care is the use of a laptop instead of the hospital PC, and a USB modem instead of a common router for the hospital LAN connection. Windows is adopted as the operating system for all computers. Telemedicine software are AMBULATORIO AD and AD MANAGER, the first installed in LHA 12 server, the second installed in the laptop used by the nurse for home data collection. AMBULATORIO AD is accessible by administrators (Telemedicina Rizzoli), controllers, nurses, GPs and specialists. Each user has their own custom interface: Administrator interface: this gives access to each other section and the deconstruction of the program. Nurse interface: this allows viewing and editing the clinical profile of the patients followed through telemedicine, booking a new visit, and checking the patient hospital admissions in the last year. Specialist interface: this includes sections for the patient's medical history, medication, data about current and previous diseases. Through this interface, it is possible to close a home visit, preparing the final medical report. GP interface: this includes almost the same fields as the specialist one, with the difference that the GP uses them just for consultation, since he does not take part in the telemedicine service. The other program is AD MANAGER, used during the home visit to collect the patient clinical data (section for the check of PM battery status and section for the acquiring of ECG trace). The user-friendly software has been specially designed for the telemedicine application. These programs are not used in usual care, since they perform operations that are not relevant there. Usual care instead uses the Aurora application for managing the electronic health records (EHR), without communication with other system components. For the telemedicine service, medical devices and the nurse laptop are connected by wire, while a UMTS connection is used to communicate data to the hospital server. In this case, a large volume of data makes data transmission slower. Sometimes the receiver needs to request the retransmission of information, delaying communication. 14. Integration requirements The two telemedicine software programs do not communicate with any information system: they communicate between each other in the synchronisation process, but clinical and personal patient data are manually inserted in the AMBULATORIO AD. So there is no integration with any component of the hospital information system. If during the home visit the nurse needs to edit some information that was not previously imported from AMBULATORIO AD, he/she has to consult the paper patient medical record. By contrast, in the normal hospital service, the specialist can obtain patient information through HIS and LIS from his/her workstation. In Public Page 58 of 92 v1.0 / 4th April 2011

59 particular, this integrates with LHA 12 and hospital Central Registry, with the booking office, medical repository, ADT system and RIS. Standards used for the document sharing are HTML, JPEG for images and MPEG for multimedia, the same as for the normal outpatient service. Standards for communication are HTTP and secure HTTPS version. No guidelines are followed for medical devices integration at the patient s home, since the program for instrumental data collection installed on the nurse laptop does not communicate with any other information system. 15. Technical support The patient is passively involved in the service, since he does not interact directly with technology; he can not access the application for his data management. Healthcare professionals using telemedicine have several sources of technical support, such as some reference persons, website and telemedicine handbook Domain 2 - Safety TECHNICAL SAFETY 1. Back-up systems Back-up procedures run daily for the LHA 12 management server, under the supervision of the Information System section. There are also regular checks and interventions on the system. 2. Errors in communication or failures There is no predetermined range within which the acquired values must fall to be considered valid. So in the case of wrong data entry, or clinical values exceeding thresholds, there is no error message. Other possible errors can occur with patient personal data, since their insertion is manual. In order to correct them, the nurse must log on to AMBULATORIO AD program, change the erroneous fields and save; while if the same patient data are inserted twice, it is not possible to correct the error. Only if two patients with the same health insurance card are inserted does an alert identify the error. In case of failure (e.g. no Internet connection available), there are other channels for communication. Instead of sending the data immediately after acquisition, the nurse can start the synchronisation process once he/she arrives at the hospital, connecting the laptop to the hospital LAN or directly to the specialist PC. This situation has occurred several times since the service started. Lack of connection is not a problem for data capture at the patient s home, as the dedicated software does not require internet connection. 3. Antivirus programs For PCs protection, Office Scan antivirus software is used. When it runs, however, it normally slows the system considerably. Public Page 59 of 92 v1.0 / 4th April 2011

60 4. Performance tests No performance test are planned for the devices and software. However, in order to verify the connection efficiency, one of the nurses carried out tests in several locations in Venice centre, noting that in some areas (e.g. the island of Murano) it was not possible to establish the connection. In these cases the off-line mode is used as explained above. 5. Experience in technology Experience in using technology significantly affects the proper working of the system. Lack of experience in this sense would cause problems such as loss of data, wrong synchronisation between PC and the server, and/or wrong data capture. 6. Privacy and data security In order to ensure data security, a virtual private network (VPN) is activated when data are transmitted through UMTS connection. The specialist does not use digital sign for medical report authentication, but it is used for laboratory tests. Patient data are stored in the server repository that makes them available for all client programs. Patient data are manually inserted in the clinical profile through the AMBULATORIO AD software, without connection with LHA registry, since there is no integration. Database access is allowed to: Specialist (not just the cardiologist, but also all other specialists involved in the care process): he/she can view and edit all the patient data. Nurse: he/she can view and use the demographics data and those acquired during the visit. System Administrator: he/she can access all sections of the application; he/she may view the personal data of the patient, but not the clinical ones. The patient cannot access to the database. All these operations require the same identification system for all authorised users, with personal credentials (user-id and password provided off-line by administration), that are changed every 60 days. Regarding patient data edit, it is always possible to correct the demographic information, but not those acquired during the home visit, once it is concluded. If some instrumental data have to be acquired again, the nurse must necessarily book a new visit, synchronise again, re-plan the access and reexamining, recovering the remaining clinical data with copy / paste system. According to the opinion of those interviewed, the solution adopted is the best in terms of data security, even better than programs used in normal hospital practice. For all the procedures described in this section, there is a support manual to guide the healthcare staff Domain 5 Economic aspects For an analysis of results, the cost of a single arterial blood gas analysis was estimated. Public Page 60 of 92 v1.0 / 4th April 2011

61 The tables below show, for usual care and telemedicine respectively, the running costs for one emogas analyser, distinguishing between: The consumption of resources. The cost of resources. The calculation of these data determines the total value (Euro) for those resources for one single visit (considering the specific arterial blood gas analysis). Table 7 below shows the resources used for one arterial blood gas analysis. Patient resources were gathered from telephone interviews; details of these are shown in Table 9. Table 7 Consumption of resources for one arterial blood gas analysis (comparison between usual care and telemedicine) Running costs: consumption of resources for 1 emogas analysis Traditional Telemedicine Travel Public transportation for the nurse / 2 trips Time the patient spends to get to the hospital 72,5 minutes / Cost of the transportation of the patient to the hospital and back 2 trips / Equipment Emogas reagent 1 unit 1 unit Disposable syringe 1 unit 1 unit Staffing Cost of the lung specialist 20 minutes 10 minutes Cost of the nurse (including travel time) 20 minutes 30 minutes Cost of time Time of the patient (excluding travel) 38 minutes 20 minutes Relatives' time (including travel) 72 minutes 20 minutes The costs of the resources needed for one arterial blood gas analysis are shown in Table 8 below. The unit costs used to derive these costs are shown in Table 10. Public Page 61 of 92 v1.0 / 4th April 2011

62 Table 8 Costs of resources for one arterial blood gas analysis (comparison between usual care and telemedicine) Running costs: cost of resources for 1 emogas analysis Traditional Telemedicine Travel Public transportation for the nurse / 3,00 Time the patient spends to get to the hospital 6,24 / Cost of the transportation of the patient to the hospital and back 51,50 / Equipment Emogas reagent 11,00 5,00 Disposable syringe 1,00 1,00 Staffing Cost of the lung specialist 10,00 5,00 Cost of the nurse (including travel time) 6,20 9,30 Cost of time Time of the patient (excluding travel) 3,32 1,73 Relatives' time (including travel) 18,13 4,99 TOTAL 107,39 30,02 The table below shows the data collected from the five patients we contacted via telephone interview. One of them refused to answer; therefore the data refers to four people. The questions, the answers of each of them and the average values are reported. Public Page 62 of 92 v1.0 / 4th April 2011

63 Table 9 Patients telephone interviews: questions and answers The table below describes, for each cost item, the specific resource and its unit cost. A version of this table was used in order to calculate the unit cost of the visits, reported in the following figure. Public Page 63 of 92 v1.0 / 4th April 2011

64 Table 10 Detailed data of the unit cost of resources Literature (Drummond, 2000) suggests that uncertainty be explored via a sensitivity analysis. We therefore varied the number of analyses carried out over a four year period. The numbers we used are 25, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400; they represent the equivalent annual number of analyses. These numbers have then been added to the average number of telemedicine examinations carried out annually by the hospital in the period 2007 to Figure 7 shows that the cost of one arterial blood gas analysis is smaller for the traditional option when less than 244 yearly analyses are performed. After that number of analyses, telemedicine is increasingly cheaper. The steeply decreasing shape of the red curve is due to the greater amount of investment needed for telemedicine. It should also be said that the real number of annual analyses that equals the unit costs for the two alternatives might be lower: in particular, it has not been possible to evaluate the start-up costs and some fixed costs ascribable to the traditional alternative. Public Page 64 of 92 v1.0 / 4th April 2011

65 Euros D3.3 Critical assessment of the test application of 250 Unit cost of arterial blood gas analysis Analises per year Traditional Telemedicine Domain 6 Organisational aspects PROCESS Figure 7 - Results from sensitivity analysis 1. Changes in organisational workflows, tasks shift With the new service, the specialist is limited to reporting at end of the visit (completed in 15 minutes). If necessary, this is done in consultation with the nurse who is at the patient s home, saving significant time. In this way, he can follow a larger number of patients. For the nurse, however, responsibilities and workload increase, because he/she directly carries out the visit and decides on any further analysis. Even though the home visit has the same duration as an outpatient visit, the nurse altogether takes more time (one hour and 45 minutes), because he/she has to go to the patient s home. Usually in one day he/she is able to carry out 8-10 home visits, corresponding to a smaller number of patients than the normal outpatient clinic. There are no other professionals that change the way they work. The nurse personally manages the booking diary. There is no need for a dedicated telematic centre that connects patient and specialist, as there is no excessive data flow. The patient also deserves consideration because, although he/she does not have an active role in the service, he/she can count on the possibility of being followed up at home, leading to significant time savings. 2. Staff training Compared with the traditional alternative, the number of nurses involved in the service decreases. The specialists are the same as those who normally take the outpatient clinics, but not all those working at LHA 12 are taking part in the Public Page 65 of 92 v1.0 / 4th April 2011

66 telemedicine programme. There are no other professionals required for the application. As mentioned earlier, for those involved in telemedicine, knowledge is required on the operation of the computer systems, together with some practical experience in using technology. For this reason, training activities are intended for nurses and sometimes for the specialists. It consists of meetings, theory and practical lessons, including insights of a purely technological nature. To do this, the Telemedicine group held courses for a total of five full working days. 3. Interaction and collaboration The telemedicine service increases collaboration and trust between medical specialists and nurses. This, according to the respondents, involves the optimisation of care time. Nurses have more autonomy, especially in decision-making, since they have to determine first hand what to do during the home visit. During the home visit, the patient interacts only with the nurse, and not with the specialist as normally happens in clinics. The patient is duly informed about the service and its benefits. Thanks to this health education, the patient is encouraged to take responsibility for the management of his/her disease, unlike what happens with the hospital service. Other collaborations take place with family members and carers. With the patient s consent, relatives are constantly informed about the patient's clinical situation and act as intermediaries with the GP, who however does not take part in the telemedicine service. Carers give mostly logistical assistance in organising the home visit. CULTURE 4. Clinical staff perception towards telemedicine In general, all the professionals involved are largely satisfied with the service. However, only nurses are encouraged to use telemedicine. Medical specialists give their availability rather spontaneously, GPs do not engage voluntarily. The initial difficulties are related to lack of confidence in using the technology. In order to avoid any delays in carrying out the home visits, a lead person of the telemedicine team initially accompanied the staff. There have never been problems with the overlap of the professional roles. Right from the start, it was clear to all professionals involved what their duties were, thanks to the support of a clear telemedicine handbook. MANAGEMENT 5. Management Overall responsibility for the telemedicine service lies with LHA 12, which, through the business group of Telemedicine and the Scientific and Technical Committee, determines any possible changes. Public Page 66 of 92 v1.0 / 4th April 2011

67 Domain 7 Socio-cultural, ethical and legal aspects ETHICAL ASPECTS 1. Potential ethical issues The service is deemed to conform to a particular target number of patients with limitations in mobility. For this reason, it does not make sense to limit this type of intervention to emergency cases. It is necessary to ensure the patient receives continuity of care from hospital to his/her home, where, thanks to the more familiar environment, he/she enjoys greater autonomy. 2. Invasiveness of service Invading the patient s home privacy is not expected to disturb the patient, who feels more at ease and at the centre of attention. The home environment is deemed suitable to host a visit such as that provided by the service, since it does not perform invasive procedures. 3. Patient involvement The telemedicine programme adhesion is proposed to the patient, giving him information on its possible advantages, such as the convenience of staying at home, avoiding travel, and getting the same clinical outcome. However, he/she is free to choose whether to continue with normal hospital visits. 4. Doctor-patient relationship Between patient and professional there is already usually a relationship of trust and confidence. Sometimes, however, for logistical reasons, it is not always the same doctor to conclude the visit, but this does not cause any influence on the patient. 5. Equity among patients All patients, with the same medical conditions, can use the telemedicine service, regardless of social status, place of residence or income. 3.5 Considerations on MAST applicability This preliminary MAST application allowed us to have a basic idea on how the MAST method can be put into effect practically, rather than just the theory from the manual. Starting from the results obtained, it was clear that there is a lot of work to have a suitable and practical evaluation tool. The first MAST test was carried out without having a sufficient knowledge on how to proceed to transform the MAST manual suggestions into an operational evaluation method. Subsequently, several suggestions and indications on MAST applicability have been received from the MAST authors for all the domains. This has helped to refine the tested domains and to begin the analysis and definition of the other ones. The starting point for the following activities were some considerations derived from the answers of people interviewed, summarised from the results presented above: Public Page 67 of 92 v1.0 / 4th April 2011

68 Need to simplify the questionnaire. A lot of questions are useless and do not bring information relevant for the assessment, especially in the first domain. Need to have closed-ended questions with response categories in order to avoid possible misinterpretation by those interviewed. People interviewed often did not understand the questions meanings without additional explanations. The results obtained can then be compared more easily with those obtained from other applications using the same method. Need to identify the right people to address the questions to before the assessment starts. Need to understand what the literature review is for. At the beginning, it was not clear enough if it is to help the selection of the topics to be included in the assessment, or for the analysis of the results obtained (in order to provide a comparison term). Need to have more information on how to carry out the economic analysis. Need to have more time to identify the cost entries. Even if the MAST manual provides a guide, through its final tables, for itemising the cost items, this phase is crucial, and one of the most time-consuming. Need to cooperate, for each domain definition, with experts in the corresponding field. In order to have a multidisciplinary vision of the problem, the best solution is to involve people having competences in each sector considered. Need to understand how the results transferability analysis has to be carried out in the RH context. Need to understand what is the chronological order for the evaluation of domains. Public Page 68 of 92 v1.0 / 4th April 2011

69 4. improvement and development The results of the first application of have pointed out the need to refine the method in order to have a better structured tool, able to identify only the most relevant aspects about telemedicine, and at the same time, easy to understand by the persons who may be involved in the assessment. This chapter describes the approach that has led to the refinement of the method into a more suitable evaluation tool. Chapter 5 presents some issues which are still outstanding. If the starting point for the first test was just the MAST manual and a literature review, in the succeeding months, MAST activities have been supported thanks to some material provided by the MAST authors that start to define better the evaluation domains. 4.1 Further activities In addition to the scientific literature review, some experts have been involved in the supervision of the development of questionnaires for domain 1 (clinicians for the definition of topics of health problem and description of the application, and computer scientists for the technical characteristics) and for domain 2 (experts in computer security for the study of the technical safety). Thanks to their support, a more accurate selection of topics has been made. Questions have been simplified, but, at the same time, made more precise and enriched with response categories that help with their correct interpretation. With regard to the economic analysis, MAST authors have sent some useful suggestions on how carry out the evaluation through six main steps. In addition, the ethical domain has been revised and completed according to the feedbacks from the WP7 Security, privacy and ethical issues. Some other contributions have been provided by MAST authors regarding the application of the method: Scientific literature review: the purpose of this survey has been clarified. The purpose is both to identify the outcome measures for telemedicine that have been used in literature so far, and to have a comparison for the results obtained with the HTA evaluation of the telemedicine service. Transferability of the results obtained: in the RH context, by producing a good scientific study of the effects of the telemedicine application where patients, telemedicine application and results are well described, it will be easy for other regions and countries to assess the transferability of the results to their setting. Timing of the evaluation: MAST authors gave suggestions on the possible chronological order to be followed for the evaluation of domains. As already specified in the Manual, the assessment has to be preceded by some considerations about the aim of the telemedicine application, the relevant alternatives, and the level of the analysis. Then, the first domain should serve as a background for the multidisciplinary assessment, since it includes several issues that will fall within the other domains. The next step requires the definition of the clinical protocol describing how and when data have to be collected about clinical outcomes (domain 3), safety outcomes (domain 2) and Public Page 69 of 92 v1.0 / 4th April 2011

70 patient satisfaction (domain 4). Then, the way to collect data about economic and organisational aspects (domain 5 and 6) has to be described. With regard to economic evaluation, useful guidelines are provided about the six important steps in economic evaluation. Patient perception: a standard questionnaire for the evaluation of patient perceptions has been provided. It was not possible to find in literature a validated questionnaire on patient satisfaction about telemedicine, so a new form developed by English researchers has been proposed, since it is being used in UK as part of another programme similar to RH. Clinicians perspective: some open-ended questions have been provided for the organisational domain, in order to be able to evaluate cultural outcomes related to the clinicians perception of the telemedicine application. A minimum dataset that all pilots must collect: a document has been provided with the description of data collection with regard to: 1. Demographic data. 2. Data on effects on health related quality of life. 3. Data on patient perception. 4. Data included in the economic evaluation. 5. Data on organisation of the telemedicine service. Some of the documents to be used for the evaluation of domains (such as the questionnaire for patient acceptability, minimum dataset to be collected in all pilots, questions for cultural outcomes evaluation) need to be translated into the national languages following specific guidelines. A guide has been provided in order to ensure that results from different countries can be compared. The guide describes how back-translation should be carried out, and what they should document. The section below describes how the domains presented in the previous paragraphs have been modified according to the new activities and suggestions on MAST use. 4.2 New domains definition Once the first version of the domains was applied and the results obtained, the need to streamline the questionnaires was evident, identifying only the aspects relevant for the evaluation. The common starting point was both a more accurate literature review, and at the same time, the involvement of experts able to guide the specification of topics. However, these two activities may not have the same efficacy without the background experience obtained from the first MAST test application, and the better knowledge about MAST model acquired during the later months. Below, the results of these new activities, supported by suggestions received from the MAST authors, are presented domain by domain Domain 1 - Health problem and description of the application For this domain, the critical issue was to identify which are the aspects sufficient to give a general outline of the telemedicine service, without detailing too much in this background analysis and overlapping with the other domains. The first MAST test application determined the necessity to make a broader selection among topics proposed in the manual, and at the same time, to add other items that could be important. A more targeted scientific literature review was carried out on studies Public Page 70 of 92 v1.0 / 4th April 2011

71 dealing with telemonitoring services in Europe. Medical doctors and local experts have been involved to guide the identification of topics and the specification of questions with response categories for all the clinical and telemedicine-related issues. For the technical section, computers scientists have collaborated to better define the possible technical characteristics of the telemedicine application. Below the new questionnaire is shown. This is the final version that will probably be used for the RH pilots in Veneto Region. HEALTH PROBLEM 1. Definition of the target condition/disease 1.1 How are patients with cardiovascular diseases divided according to pathology? Artherosclerosis 0% Angina pectoris 0% Cardiomyopathy 0% Myocarditis 0% Heart failure 0% Valvular heart diseases 0% Pericarditis 0% Arrhythmia 0% Vascular diseases 0% Congenital heart diseases 0% Other 0% 2. Symptoms 2.1 What are the main symptoms? Dyspnea Chest pain Cyanosis Cardiac syncope Palpitation Oedema Cough Hemoptysis Weakness cturia Fever 3. Number of patients 3.1 According to NYHA classification, how many patients with cardiovascular diseases are treated (in general) by ULSS 12? Level I Level II Level III Level IV Public Page 71 of 92 v1.0 / 4th April 2011

72 3.2 What is the percentage ratio male/female? M 0% F 0% 3.3 What is the mean age? years years years years 3.4 On average, how many admissions were there for patients with cardiovascular diseases in the previous year? (n admissions) 3.5 On average, how many primary care visits (GP, outpatient visits, etc.) were there for patients with cardiovascular diseases in the previous year? (n primary care visits) 3.6 On average, how many specialist visits were there for patients with cardiovascular diseases in the previous year? (n specialist visits) 3.7 On average, how many visits to ER have there been for patients with cardiovascular diseases in the previous year? (n visits to ER) 4. Burden of disease, resource use 4.1 What is the mean mortality rate for patients with cardiovascular diseases? (Mortality rate: deaths / n patients with CVD*100) 4.2 What is the mean morbidity rate for patients with cardiovascular diseases? (Morbidity rate: n CVD patients / n people under LHA What are the annual costs for disease management by LHA 12? (Thousands of ) 4.4 What types of health professionals are involved? Specialists GPs Nurses Anaesthetists Pharmacists Radiologists Nutritionists Psychologists Caregivers s 4.5 Which is the first contact for patients with cardiovascular diseases? GP Health district ER Hospital Public Page 72 of 92 v1.0 / 4th April 2011

73 DESCRIPTION OF THE TELEMEDICINE APPLICATION 5. Features of the application 5.1 What is the type of telemedicine service? Telemonitoring (24h and/or on demand) Tele-counselling Tele-laboratory Tele-assistance 5.2 Is the patient assisted by healthcare professional during the service?, it is a telemonitoring service assisted by nurses, it is a self-monitoring service Both the solutions above, according to the patient conditions 5.3 Which (and how many) actors are involved in the telemedicine service? Specialists GPs Nurses Pharmacists Systems administrators LHAs Specific health institutions Computer technicians / health technologists Psychologists Caregivers Patients Relatives s 5.4 Regarding the timing of interactions, how is the telemedicine service delivered? Synchronous Asynchronous 5.5 Is the telemedicine service a long-term service?, its delivery depends on patient s condition, it is undergoing experimental tests 6. Service architecture 6.1 Which (and how many) devices are used for the telemedicine application? PC desktop Laptop PDA Webcam Microphone Telephone Modem Sensor-connected devices for wireless communication Electrocardiograph ECG devices with leads Impedance transducer Public Page 73 of 92 v1.0 / 4th April 2011

74 Blood pressure meter Coagulometer Pulse-oximeter Thermometer Weight scale 6.2 Who uses them? Patient Specialist Nurse Others PC desktop Laptop PDA Webcam Microphone Telephone Modem Sensor-connected device Electrocardiograph ECG devices with leads Impedance transducer Blood pressure meter Coagulometer Pulse-oximeter Thermometer Weight scale Other 6.3 What is the nurse role? Telephone assistance to the patient Measuring clinical parameters at patient s home Reading and filtering of monitored data Direct management of emergencies Provide the patient with the instructions on how to use the telemonitoring kit Interface between patient and specialist 6.4 What is the specialist role? Writing the medical report Second opinion for the nurse Second opinion for the GP Second opinion for another specialist involved in the patient care process Telephone assistance to the patient Reading of monitored data Direct management of emergencies 6.5 What parameters are measured with the telemedicine service? ECG Blood pressure Pulse rate Temperature Weight Oxygenation Public Page 74 of 92 v1.0 / 4th April 2011

75 Glycemia Lifestyle (mobility, falls, diet, etc.) 6.6 What other patient data are collected? Clinical parameters (specify which ones) Personal data (specify which ones) Medical history Reason of the visit 6.7 What interface is used to connect the patient home and hospital / centre for data collection? Smart modem Router Internet key PC Server Mobile phone PDA Set-Top-Box 6.8 Is the data transmission an automatic process?, data are automatically transmitted to the gateway, data are transmitted directly to the web server, data are manually inserted and transmitted, data are imported (e.g. from an external hard-disk, USB flash drive, etc.) 6.9 Where are collected data stored? Hospital server Server of external centre for data collection (e.g. device provider) 6.10 Is there a preliminary automatic data processing? 6.11 If yes, is there any alert when data exceeds thresholds or data are incorrectly entered? 6.12 Who is the first person who manages these alerts? Nurse Specialist External call centre Device providers GP s 7. Training courses and assistance for using the technology 7.1 How are healthcare staff trained to use the telemedicine system? Traditional face-to-face class Videoconference class Public Page 75 of 92 v1.0 / 4th April 2011

76 e-learning Handbook 7.2 What technical support is provided for healthcare staff having problems in using the telemedicine system? Health Specialist Nurse district Reference to technical staff Handbook Toll free number for assistance Website Other 7.3 Does the patient interact directly with technology during service delivery? 7.4 If yes, what kind of support does the patient receive? Vendor s reference personnel Health district reference personnel Health professional Handbook Toll free number Website 8. Users of the application 8.1 What are the inclusion / exclusion criteria for the telemedicine service? Age Gender Diagnosis (level of disease) Presence of risk factors Family environment ISDN availability 8.2 Who decides when the patient can use the service? Specialist Health district medical practitioner GP Nurse s 8.3 Which diseases do the telemedicine patients have? Artherosclerosis Angina pectoris Cardiomyopathy Myocarditis Heart failure Valvular heart diseases Pericarditis Arrhythmia Vascular diseases Congenital heart diseases Public Page 76 of 92 v1.0 / 4th April 2011

77 8.4 Why have these diseases been selected? Need for early discharge Need for continuing care Monitoring and prevention of acute events Highest number of improper ER visits Highest number of improper hospital admissions Highest number of acute events 8.5 Which areas are provided with the telemedicine service and what percentage of LHA 12 territory does this correspond to? Health district % Province Which ones? Region 8.6 Why have these areas been chosen? Broadband coverage Percentage rate of patients Inaccessible locations Distance from the hospital 8.7 Is it probable that the telemedicine service will be extended to a larger group of patients? 8.8 If yes, considering the service characterisation, what are the barriers for its wider deployment? Economic reasons Lack of evidence about potential benefits Insufficient funds Sluggishness of bureaucracy Organisational problems Lack of experienced staff Lack of adequate health professionals Lack of adequate training courses Difficult collaboration with the healthcare Districts Difficult collaboration with GPs Ethical and cultural barriers Technical problems Inadequate and/or unclear regulations Lack of coordination at regional level Infrastructure barriers Lack of vendors Lack of adequate standards 9. Lifecycle of the telemedicine application 9.1 Has the telemedicine application been directly tested before it becomes regular practice? Public Page 77 of 92 v1.0 / 4th April 2011

78 , because it has already been tested in another context 9.2 If yes, how long did this period last before the service became regular practice? The service has been limited to the testing stage 6 months 1 year > 1 year 9.3 How long has the telemedicine application been a regular practice? 6 months 1 year > 1 year 9.4 Has the telemedicine service been delivered without interruptions since it was activated? 9.5 If not, why was it interrupted? Economic reasons Lack of evidence about potential benefits Insufficient funds Sluggishness of bureaucracy Organisational problems Lack of experienced staff Lack of adequate health professionals Lack of adequate training courses Difficult collaboration with the healthcare Districts Difficult collaboration with GPs Ethical and cultural barriers Technical problems Inadequate and/or unclear regulations Lack of coordination at regional level Infrastructure barriers Lack of vendors Lack of adequate standards 10. Platform adopted 10.1 Were the adopted solutions already on the market?, the telemedicine service is a system integration, they have been created just for the telemedicine application 10.2 Which vendors have been involved? Device S/w H/w Other 10.3 Which factors have been considered for the vendors selection? Very good cost-benefit ratio Public Page 78 of 92 v1.0 / 4th April 2011

79 Better support service Efficiency of electro-medical devices Efficient communication technology User-friendly portal for health professionals Good case history 11. Qualitative standards 11.1 Do the telemedicine procedures meet ISO 9001:2000 certification?, because the LHA does not obtain this certification 11.2 Which European directives have been followed for the medical devices? 90/385/CEE - Dispositivi Medici Attivi Impiantabili 20/06/1990 [emendato col D. lgs , n. 37] 93/42/CEE - Dispositivi Medici 14/06/1993 [emendato col D. lgs , n. 37] 2007/47/CE - Dispositivi Medici 5/09/2007 Revisione delle Direttive 90/385/CEE e 93/42/CEE [emendato col D. lgs , n. 37 Applicazione dal 21/3/2010] s 11.3 According to the CEE directive, which category do the medical devices used belong to? Class I Class IIa Class IIb Class III 11.4 Which EN ISO technical regulations (quality, security, risk management) are considered for medical devices? EN ISO 13485:2003 Medical Devices, Quality Management Systems Requirements for regulatory purposes CEN ISO/TR 14969:2005 Medical Devices - Quality Management Systems Guidance on the application of ISO 13485:2003 EN ISO 14971:2007 Medical Devices Application of Risk management to medical devices s TECHNICAL CHARACTERISTICS 12. Infrastructure requirements 12.1 What kind of architecture is considered for the telemedicine network? Client-server Between the PC downloading data from devices and server/pc in the hospital Between device and server/pc in the hospital Peer-to-peer Web server 12.2 What are the hardware components of the telemedicine service architecture? Medical devices Public Page 79 of 92 v1.0 / 4th April 2011

80 Gateway Mobile devices PC at patient s home Interface (the connection between device and PC) Web server in hospital Peripheral server PC in hospital Firewall Switch 12.3 Which software applications are used for the telemedicine application? Videoconference software Tele-assistance software LIS software (clinical hospital Laboratory Information Systems Software) PACS software (digital medical image management and communication) 12.4 How is the patient s home connected to the hospital? ADSL Wi-Fi GPRS/UMTS PSTN (Conventional telephone network) By satellite 12.5 Which technology is used for sensors-gateway communication? Wireless Medical bluetooth and/or infrared Zigbee By cable (Ethernet, USB, EIA RS ) Modem for telephone connection 13. Interoperability 13.1 Which information systems are interoperable with the telemedicine application? Veneto Region information system (Sirv Interop platform) Health districts information system Hospital information system (HIS) GPs information system Laboratory information system (LIS) 13.2 Which of the following information systems is the telemedicine application interoperable with? Central LHA register office Central hospital register office Booking office Medical report repository ADT patient management system (Admission, transfer, and discharge) EHR of GP Public Page 80 of 92 v1.0 / 4th April 2011

81 13.3 Have you already taken actions to guarantee interoperability with EHRs according to the EC recommendations about cross-border interoperability of EHR (M403)?, I have never heard about it 13.4 Which information systems are interoperable with the applications used in the usual care? Veneto Region information system (Sirv Interop platform) Health districts information system Hospital information system (HIS) GPs information system Laboratory information system (LIS) 13.5 Which of the following information systems is the usual care application interoperable with? Central LHA register office Central hospital register office Booking office Medical report repository ADT patient management system (Admission, transfer, and discharge) EHR of GP 14. Standards 14.1 Which standards have been adopted for clinical data exchange? HL7 (exchange of clinical data) DICOM (exchange of radiological images) ISO/IEEE 1073 P1073 (Medical Interface Bus) NCDPDP (exchange of pharmaceutical information) E1381/1394 (exchange of laboratory data among computer and medical devices) E1460 (link between knowledge-based system (KBS) and clinical database) E1467 (exchange of digital neurophysiological data) 14.2 Which standards have been used for data communication? HTTP (Hypertext Transfer Protocol) HTTPs (Hypertext Transfer Protocol over Secure Socket Layer) RTP (Real-time Transport Protocol) FTP (File Transfer Protocol) SFTP (SSH File Transfer Protocol) 14.3 Which standards have been used for data sharing? HTML (HyperText Markup Language) XML (extensible Markup Language) PDF TXT Public Page 81 of 92 v1.0 / 4th April 2011

82 CDA2 DICOM for images JPEG for images MPEG 15. Back-up procedures and systems 15.1 Regarding the telemedicine application, does a regulation about back-up procedures and systems exist within the security policies? 15.2 Who is responsible for the back-up procedures? The specialist himself The nurse Computer scientist System administrator s Domain 2 Safety (technical safety) The second domain required the guidance of experts to be better structured, in questions with response categories. A group of experts on computer security has been involved for this purpose; they helped to put the focus on the technical reliability of the telemedicine system, conceived as a model with different components that communicate data one with the other: Medical devices for instrumental data capture at the patient s home. Gateway device for transmission of data acquired at the patient s home to a central data warehouse. Central server for data warehouse. In addition to new questions on the service level agreement, data security is analysed taking into particular account the concept of data privacy, integrity and availability, at each level of components that characterises the telemedicine service. TECHNICAL SAFETY 1. Service levels agreement 1.1 What are the service level agreements for the telemedicine service? Telemedicine adopted software performance Main network devices performance Effective connection speed Devices performance Data availability 1.2 What are the service level agreements for patient security? Health professionals response time in case of complications Response time in case of equipment malfunctioning Minimum connection speed to the central server for data collection Service reactivation time in case of black-out Public Page 82 of 92 v1.0 / 4th April 2011

83 Service reactivation time in case of system maintenance Call centre response time 1.3 What are the advanced features of the antivirus software? File system scanner software at regular intervals Central distribution of updates Possible updating through Internet 1.4 What risk management activities are expected for telemedicine device management? Risk analysis Risk estimation Risk evaluation Risk control Risk management 2. Use of technology 2.1 Who has the responsibility in case of technical problem? Vendors Health district Specialist Nurse Installation errors Ineffective installation Inadequate management Transmitted data corruption Sudden equipment breakage Erroneous data interpretation Wrong diagnosis 2.2 How has the use of technology influenced the telemedicine start-up? System integration has been simple There have been problems due to the lack of standards Telemedicine is a closed system which is difficult to integrate There have been organisational problems, as the procedures are not so clear 2.3 Do the health professionals need technological experience to use the telemedicine application? 2.4 What are the main difficulties encountered by the patient in using this particular technology? Insufficient technological proficiency Difficulties in understanding technical jargon used by medical staff Improper use of the devices Forgetting to use the devices 3. Data privacy 3.1 What protocol is used to transfer data from the sensor and the gateway? Medical bluetooth Public Page 83 of 92 v1.0 / 4th April 2011

84 Zigbee 3.2 What kind of protocol is used to protect connection for the communication with patient s home? HTTPS (Secure Hypertext Transfer Protocol) SSL (Secure Sockets Layer) PCT (Private Communication Technology) S/WAN (Secure/Wide Area Network) PPTP (Point-to-Point Tunnelling Protocol) per VPN L2TP (Layer 2 Tunnelling Protocol) per VPN IPSec (Internet Protocol Security) per VPN 3.3 What is the degree of encryption used to protect the data? Public key encryption Symmetric encryption Asymmetric encryption 3.4 Are the encrypted channels activated automatically, without the patient s intervention? 3.5 May non-transmitted data be viewed by anyone (without authorisation)? 3.6 Does the system dedicated to the management / elaboration of the collected data require authorisation for access? 3.7 If yes, with what credentials? Weak (password and user-id assigned on-line) Medium (password and user-id released off-line by the administration) Strong (need to use a PC equipped with a smart card reader and to know the pin code of the authorised card) 3.8 Who can access the DB and what kind of data can they access? All Clinic Lifestyle Anagraphical Statistics Specialist Nurse System administrator Patient Other specialists 3.9 Does the system have data anonymisation mechanisms in case they are sent to third parts for statistical purposes? 4. Data integrity 4.1 Can the patient modify the data once they have been acquired? Public Page 84 of 92 v1.0 / 4th April 2011

85 4.2 In the acquisition phase, can the data integrity be impaired in any way by electromagnetic interference (generated by domestic sources)? 4.3 Does the acquisition device communicate if data are correctly collected (for instance through optic or acoustic signalling)?, always, but only if an error occurs, but only if the acquisition has been successfully accomplished 4.4 What happens in case of incorrect data acquisition / input? thing Automatic alarm and consequent nurse s intervention Automatic alarm and consequent GP s intervention The data are automatically discarded by the device and a new acquisition is required Intervention, at a later stage, by the medical specialist who notices the anomaly 4.5 Does the transmission device check the consistency of the data sent, reporting that data are correctly collected? 4.6 Does the transmission device allow the modification / alteration of the data to be transferred to the centre dedicated to data collection? 4.7 Does the data processing system prevent amendment of the data collected? 4.8 Who is responsible for any alteration or modification of collected data? Medical specialist Nurse Patient s 4.9 Does the data processing system check the correct association between data collected and the corresponding patient? 4.10 Does the data processing system provide control, signalling and anomalous values verification mechanisms? 4.11 When is digital signature used (as a means of legal support)? Telemedicine service Usual care Communication between LHAs Public Page 85 of 92 v1.0 / 4th April 2011

86 5. Data availability Communication between medical specialists Medical reports It is not regularly used 5.1 Can the acquisition device work without electricity?, the absence of electricity is tolerated, measurements are postponed to the moment when electricity is again available, partially. The devices have batteries enabling them to temporarily save a certain part of the measurements, the devices are linked to a UPS providing electricity for long periods of time 5.2 What happens if the measuring probe breaks? The situation can be tolerated. The measurement will be performed the following day, after the repair of the device The situation can be tolerated, since a spare probe is provided The situation cannot be tolerated. The probes are continuously monitored and any anomaly is immediately signalled to the person responsible at the operations centre, who will promptly provide a substitute 5.3 Can the data transmission device work without electricity? 5.4 Can the data transmission device work without a phone line? 5.5 Is the data transmission device able to advise the data collection centre in case of any anomaly / malfunction? 5.6 If the communication devices do not work properly, what other channels can be used to guarantee communication with the hospital? Toll-free phone number Call Centre Home assistance Information desk Videoconference 5.7 Does the data processing system ensure the availability of the data at any time? 5.8 What kind of back-up is provided? Complete back-up Differential back-up Incremental back-up 5.9 How often? Daily Weekly Public Page 86 of 92 v1.0 / 4th April 2011

87 Monthly Quarterly 5.10 Since the telemedicine service is active, has it ever been necessary to adopt data recovery procedures? 5.11 Is the data management system able to analyse the signalling of the remote device, in order to evaluate the efficiency and reliability of the data transmitted? Domain 5 Economic aspects The most recommended economic analysis would be a cost-effectiveness analysis able to weight the costs due to telemedicine introduction with its concrete clinical effectiveness. For the first test, a cost-minimisation analysis was preferred for the reasons described in the previous chapter. The document received in the later months ( Six important steps in the estimation of the economic aspects of telemedicine applications in Renewing Health ) has been useful in presentation of analysis results, as it provides some tables that help to report the types of resources included in the estimation of costs, the modality for data collection, and the prices used in the calculation of costs. Example of the types of resources included in the estimation of costs (Table 11) and the prices used in the calculation of costs (Table 12) are shown below. Table 11 Example of types of resources included in the estimation of costs Public Page 87 of 92 v1.0 / 4th April 2011