- Email: [email protected]
Development and daily use of an electronic oncological patient record for the total management of cancer patients: 7 years’ experience
original article
Annals of Oncology 20: 349–352, 2009 doi:10.1093/annonc/mdn567 Published online 20 August 2008
Development and daily use of an electronic oncological patient record for the total management of cancer patients: 7 years’ experience E. Galligioni1*, F. Berloffa2, O. Caffo1, G. Tonazzolli2, G. Ambrosini1, F. Valduga1, C. Eccher2, A. Ferro1 & S. Forti2 1
Department of Medical Oncology, Santa Chiara Hospital; 2eHealth Applied Research Unit, FBK-irst, Fondazione Bruno Kessler, Trento, Italy
Received 18 February 2008; revised 18 July 2008; accepted 21 July 2008
Background: We describe our experience with an electronic oncological patient record (EOPR) for the total
introduction Despite impressive technological advances in healthcare over the last 20 years, patient records (PRs: the repository of patient history and the main support in clinical decision making) are still largely paper based. Many types of electronic PRs have been tried, but very few have become a routine part of total patient management and these vary widely between countries and specialties [1]. Information technology (IT) has therefore failed to achieve the same degree of penetration as it has in other fields, like the finance, transport, manufacturing and retail sectors, and we are still far from a paperless hospital [2–4]. A recent survey carried out by the Italian Ministry for Innovation and Technologies found that only 40% of healthcare organisations have adopted an IT system, mainly for administrative purposes, and a White Paper published by the Italian Association of Medical Oncology in 2004 reported 49.2% of 319 Medical Oncology Units were still using paper-
based PRs, 48.8% a mixed paper and electronic system and only 1.3% exclusively electronic PRs for the entire management of cancer patients [5]. Cancer is a highly complex disease that often presents alternating phases of tumour remission and progression and may require multiple therapeutic strategies involving different healthcare professionals. As suggested by the American Institute of Medicine, this complexity would greatly benefit from IT support to improve the timeliness and accuracy of information, as well as the quality of cancer care [6, 7]; however, the major challenge facing IT is managing the entire clinical course of single and multiple individual cancer patients. In June 1997, we began a 3-year project funded by the Italian Ministry of Health with the aim of designing, developing, adopting and evaluating a web-based electronic oncological patient record (EOPR) and teleconsultation module for the total management of cancer patients. This EOPR has been routinely used in our hospital since June 2000 [8–10].
methods *Correspondence to: Dr E. Galligioni, Department of Medical Oncology, Santa Chiara Hospital, Largo Medaglie d’Oro, 38100 Trento, Italy. Tel: +39-0461-903451; Fax: +39461-903364; E-mail: [email protected]
The EOPR, which was designed to allow rapid multipoint access to different users, was initially developed by combining the HTML web language with
ª The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected]
original article
training, followed by continuous assistance; user acceptance was monitored by means of three questionnaires administered after 2 weeks, 6 months and 6 years. Results: The EOPR has been used daily for all in-ward, day hospital and ambulatory clinical activities since July 2000. The most widely appreciated functions are its rapid multipoint access, the self-updated summary of the patients’ clinical course, the management of the entire therapeutic programme synchronised with working agendas and oncological teleconsultation. Security and privacy are assured by means of the separate storage of clinical and demographic data, with access protected by login and a password. The questionnaires highlighted appreciation of rapid data retrieval and exchange and the perception of improved quality of care, but also revealed a sense of additional work and a negative impact on doctor–patient relationships. Conclusions: Our EOPR has proved to be effective in the total management of cancer patients. Its user-centred design and flexible web technology have been key factors in its successful implementation and daily use. Key words: cancer patient management, digital record, electronic patient record
Downloaded from http://annonc.oxfordjournals.org/ at NERL on May 16, 2015
management of cancer patients.
Methods: The web-based EOPR was developed on the basis of a user-centred design including user education and
original article
results first prototype The preliminary investigation revealed different degrees of computer expertise among the users, who agreed to spend a limited time on data input. The task force therefore first tried to gain a detailed understanding of the care process by means of a step-by-step analysis of all clinical activities and the usual paper documentation. Data acquisition and retrieval were simplified by point and click interfaces and the use of radio buttons, check buttons and list boxes containing specific coded items. Free text fields were also allowed for relevant noncoded information. The major data and function sets were then defined and included:
Demographic data imported from the regional demographic database to avoid transcription errors and duplications. Anamnestic data, including risk factors, and past and recent medical history with chronic medications. Laboratory and instrumental data imported from the corresponding repositories, with the automatic highlighting of abnormal values. Pathological/clinical diagnosis based on the International Classification of Diseases for Oncology and tumour–node– metastasis system. Therapeutic programme, covering the entire process of care with the detailed doses, schedules, sequences and supportive drugs for all regimens. Therapies are proposed with automatic dose setting and updated sequencing (even in the case of dose modifications, treatment delays or integrated therapies), and cumulative drug doses and relative dose intensities are also automatically updated and recorded. Furthermore, all the therapies are traced with the names of the doctors and nurses and the date and time of prescription and administration.
350 | Galligioni et al.
A self-updated chronological summary of each patient’s clinical course, showing the sequence of different accesses, treatments, responses and toxic effects. Data are automatically extracted from any single patient’s access and grouped in a chronological order. Working agendas to arrange and synchronise patient appointments with the different clinical activities. Data extraction of clinical activities, patient and tumours characteristics, treatments and resource consumption, etc.
Once the core functions had been defined, different forms were designed for hospitalised, ambulatory and day hospital patients, to enable doctors and nurses to effectively manage patients in every situation. The corresponding doctors’ and nurses’ diaries were also implemented. The prototype underwent a long process of refinement by the task force, which used continuous interactive–iterative feedback to optimise the system architecture and user interface [17, 18].
system integration The EOPR initially designed for Medical Oncology was subsequently shared with the Radiotherapy Unit as a consequence of the strict interaction between units. For each patient, therefore, only one EOPR is available, implemented with specific forms, functionalities and agendas. Furthermore, other specialties (i.e. Surgery, Urology, Gynaecology, Head and Neck) were allowed to gain access to the EOPR for consultation. All relevant reports, particularly those of the multidisciplinary clinics, are imported in to the EOPR by the oncologists. Finally, the EOPR was made available to six peripheral hospitals, in which a limited oncological care is provided, to ensure a common tool for patient management and to be used for oncological teleconsultation, on specific problems, with the referral center in Trento. The teleconsultation is available with two modalities: the synchronous use of multipoint virtual meetings, supported by audio conferencing, synchronised surfing, interactive image sharing and chatting, and the asynchronous use of a patient-specific messaging service inside the EOPR work environment for short questions to and answers from a remote expert oncologist and for late medical reports. This experience, which has previously been partially reported [8, 19], will be the subject of a separate paper. privacy and security All unauthorised accesses to the EOPR are prevented by means of login and password controls associated with different profiles for doctors and nurses, each with specific permissions and limitations. To prevent the simultaneous entry of data relating to the same patient by different users, an internal lock is activated in order to restrict access for the compilation of a given EOPR to one user at a time. All accesses for data entry are recorded, with the date, time and user identification; similarly, any changes made to previous forms are traced after permanently saving the original data. Finally, the clinical and demographic data are stored separately
Volume 20 | No. 2 | February 2009
Downloaded from http://annonc.oxfordjournals.org/ at NERL on May 16, 2015
active server-side pages for the dynamic retrieving of clinical data from a Microsoft SQL Server database [7, 11]. In 2006, it was technologically revised: the graphic aspects of the user interface were entirely redesigned at presentation layer level and, at middle layer level, XML was adopted as data transportation format. This allows the clinical information contained in the EOPR to be easily mapped to the XML-based version of HL7 in order to enable data exchange with HL7compliant systems. At data layer level, the Oracle database was adopted. System development was on the basis of a user-centred design that allows end-users to influence the final product and how it takes shape [12–15]. A small task force of doctors, nurses and computer scientists analysed user requests and expectations in order to define the optimal data and function set [16] and, since its development, the prototype has been repeatedly revised in order to optimise the information content, system functions and the users’ interface. Before adopting the EOPR, the doctors and nurses were provided appropriate education and training, which was followed by on-site assistance during the initial routing and, subsequently, permanent remote assistance. User acceptance has been monitored by means of three anonymous questionnaires administered after 2 weeks, 6 months and 6 years of daily use. These questionnaires consisted of seven Likert scale statements, which were reduced to the three values of disagreement, agreement and neither in order to test for possible variations between periods.
Annals of Oncology
original article
Annals of Oncology
in the database, and the two types of information can only be correlated through the EOPR by means of an internal databinding mechanism.
user education and system roll out All the receivers attended two educational sessions aimed at clarifying the structure and functions of the EOPR, followed by training on practical simulation of new activities, both in the informatics laboratory and in working place. The doctors and nurses were trained separately in small groups, after their routine activities and the entire process required 3 months. After system adoption, users were further supported by the in-site assistance for 2 weeks, during the initial routing, and by the permanent remote assistance thereafter. The EOPR was introduced into everyday practice on 5 June 2000 for all new patients. To avoid a large unaffordable work, the existing paper-based records of previous patients were retained. EOPR was subsequently adopted also for previous patients, in case of relapse and, recently, for those still in follow-up. The number of patients entirely managed using the EOPR was therefore relatively small at the end of 2000 (566 patients), but this significantly increased by the end of 2007 to 13 878 patients, (with among others 3865 breast, 1819 colon, 1675 prostate and 1354 lung cancer patients), for a total of 130 006 different accesses. Presently, a printed copy of each EOPR is still available, for legal and regulatory purposes and for storage of paper data.
discussion We believe that the successful implementation and routine use of our EOPR over the last 7 years are due to a number of key factors. First of all, rapid multipoint access means that time is no longer taken up by searching for and retrieving records and, simultaneously, it is possible to undertake other activities, including multidisciplinary consultations and data
user satisfaction The answers to the first questionnaire, which was administered after 2 weeks of daily use, largely reflected the stress associated with the new operating procedures and the frequent requests
Table 1. Closed-response questions relating to user attitudes towards the system administered in two questionnaires 6 months (upper part of each statement row) and 6 years after system usage (lower part) Statement S1: intra- and interward information sharing and exchange have improved by using the system S2: the use of the system does not imply an additional workload S3: adoption of the system has favoured the standardisation of working procedures S4: adoption of the system has improved your professionalism S5: the quality of care has improved S6: the use of an IT system has made your relationships with patients more difficult S7: the use of an IT system makes it possible to obtain updated information concerning patient status
Responses Agree
Neither
Disagree
P
10 13 2 12 6 15 7 11 8 10 12 8 13 16
3 3 4 1 4 1 6 3 5 3 1 2 2 0
1 0 9 3 6 0 2 2 2 1 1 6 1 0
NS <0.01 <0.01 NS NS NS NS
To test possible differences between the short- and long-term, the Likert scale responses were reduced to three values: disagreement (1–3), agreement (5–7) and neither (4). v2 statistic of the resulting 2 · 3 contingency tables were used to test the null hypothesis of no changes in user attitudes, with a level of statistical significance of P = 0.01. NS, not significant.
Volume 20 | No. 2 | February 2009
doi:10.1093/annonc/mdn567 | 351
Downloaded from http://annonc.oxfordjournals.org/ at NERL on May 16, 2015
for on-site assistance. Users took an average of 2 months to become completely familiar with the EOPR. The second and the third questionnaires, which were administered in a more stable emotional phase, allow a better comparison of user opinions at different time points. Both questionnaires revealed a high degree of user motivation (86.6% and 100%), and the majority of users (100% and 88.2%) considered the EOPR reliable. In both the short- and the long term (Table 1), a large proportion of the doctors and nurses greatly appreciated the quick retrieval and exchange of updated information (S1, S7), together with the perception of professional growth (S4) and an improved quality of care (S5). A significant improvement in the standardisation of clinical and therapeutic procedures (S3) was more perceived after prolonged use in comparison with the first 6 months and, although the EOPR was considered a source of additional work by 53.4% of the users in the early phase (S2), this dropped to 17.7% 6 years later. A negative impact on doctor–patient relationships (S6) was reported by the majority of users in the early phase, and this only partially decreased in the longer term. However, taken together, both questionnaires indicated a good level of user satisfaction, with no differences between doctors and nurses.
original article
conclusions We believe that user involvement in the system design, flexible web technology, the development of appropriate functions for total patient management on the basis of clinicians’ needs and—last but not least—short- and long-term assistance are the key factors for successfully implementing and using a clinical IT system. Under these conditions, our EOPR has
352 | Galligioni et al.
proved to be effective for the total management of our cancer patients over the last 7 years. This will unable the measurement of any improvement of the quality of health care, on the basis of reliable and timely data.
funding The Italian Ministry of Health.
references 1. Jaspers MW, Knaup P, Schmidt D. The computerized patient record: where do we stand? Methods Inf Med 2006; 45 (Suppl 1): 29–39. 2. Grimson J. Delivering the electronic healthcare record for the 21st century. Int J Med Inform 2001; 64: 111–127. 3. Sands DZ, Rind DM, Vieira C et al. Can a large institution go paperless? Medinfo 1998; 9(Pt 1): 60–63. 4. Heathfield H, Pitty D, Hanka R. Evaluating information technology in health care: barriers and challenges. BMJ 1998; 316: 1959–1961. 5. Associazione Italiana di Oncologia medica. Il Libro Bianco dell’oncologia italiana. Brescia: Intermedia 2004. 6. Institute of Medicine. Guidelines for Clinical Practice: from Development to Use. Field MJ, Lohr KN (eds): Washington, DC: National Academy Press 1992. 7. Institute of Medicine and Commission on Life Sciences, National Research Council. Enhancing Data Systems to Improve the Quality of Cancer Care. Hewitt M, Simone JV (eds): Washington, DC: National Academy Press 2000. 8. Forti S, Galvagni M, Galligioni E et al. A real-time teleconsultation system for sharing an oncologic web-based electronic medical record. AMIA Annu Symp Proc 2005; 2005: 959. 9. Larcher B, Arisi E, Berloffa F et al. Analysis of user-satisfaction with the use of a teleconsultation system in oncology. Med Inform Internet Med 2003; 28: 73–84. 10. Demichelis F, Berloffa F, Eccher C et al. Design and initial implementation of a regional tele-oncology project. J Telemed Telecare 2000; 6 (Suppl 1): S71–S73. 11. Fraser HS, Kohane IS, Long WJ. Using the technology of the World Wide Web to manage clinical information. BMJ 1997; 314: 1600–1603. 12. Norman D, Draper S. User-centered System Design: New Perspectives on HumanComputer Interaction. Hillsdale, NJ: Lawrence Earlbaum Associates 1986. 13. Shneiderman B. Designing the User Interface: Strategies for Effective HumanComputer Interaction. Reading, MA: Addison Wesley Publishing Co 1987. 14. Dix A, Finlay J, Abowd G et al. Human-Computer Interaction. Upper Saddle River, NJ: Prentice Hall 1998. 15. Johnson CM, Johnson TR, Zhang J. A user-centered framework for redesigning health care interfaces. J Biomed Inform 2005; 38: 75–87. 16. Hackos J, Redish J. User and Task Analysis for Interface Design. New York, NY: Wiley 1998. 17. Participatory Design: Principles and Practices. Schuler D, Namioka A (eds): Mahwah, NJ: Lawrence Erlbaum Associates 1993. 18. Grønbæk K, Kyng M, Mogensen P. CSCW challenges: cooperative design in engineering projects. Commun ACM 1993; 36: 67–77. 19. Eccher C, Berloffa F, Galligioni E et al. Experience in designing and evaluating a teleconsultation system supporting shared care of oncological patients. AMIA Annu Symp Proc 2003; 2003: 835. 20. Masseroli M, Visconti A, Giovanni BS et al. HealthCo-op: a web-based system to support distributed healthcare co-operative work. Comput Biol Med 2006; 36: 109–27.
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extractions. Secondly, the complete and automatically updated summary of a patient’s clinical course (including treatments, responses and toxic effects) has greatly aided decision making, particularly when rapid decisions are required. Similarly, the management of the entire therapeutic programme, even in the case of different drug therapies (i.e. chemohormonal) or sequences (i.e. chemo A followed by chemo B) or integrated treatments (i.e. chemo + radio or chemo + surgery), has offered fundamental support. All appointments are automatically synchronised with the corresponding agendas and updated in the case of delays due to toxicity or other reasons, and all dose reductions or treatment modifications are proposed at the subsequent cycle in order to confirm or modify changes. Furthermore, the full traceability of all drug prescriptions and administrations has reduced clinical risk and likely improved the quality of care. Similarly, the automatic predisposition of letters and other forms has led to greater accuracy and significant time savings. Finally, the profound integration of EOPR functionalities has enabled professionals to monitor major clinical activities and resource consumption, matched against different tumours and different treatments. It is well known that it is often difficult to adopt new technologies in structured organisations like hospital units, but the user-centred design of our EOPR, and the education, training and continuous assistance provided, have greatly facilitated end-user acceptance, as is shown by the prevalence of positive responses to the questionnaires. Furthermore, any IT implementation clearly requires full integration with other hospital information systems in order to be able to exchange and share information with other diagnostic, therapeutic and administrative units, as well as with other hospitals, and this must always be considered from the beginning. In this context, web technologies and XML were the necessary fundamentals of our EOPR, which can easily be integrated with any HL7-compliant system [20]. As far as costs are concerned, the hardware includes a personal computer for every doctor and nurse working station, but these are now widely available in most hospitals and their cost has been continuously decreasing. Software costs obviously depend on the market and specific local requirements but, whatever the choice, they must include long-term assistance, which should also provide for system updating and personalisation on the basis of local needs.
Annals of Oncology
Annals of Oncology 20: 349–352, 2009 doi:10.1093/annonc/mdn567 Published online 20 August 2008
Development and daily use of an electronic oncological patient record for the total management of cancer patients: 7 years’ experience E. Galligioni1*, F. Berloffa2, O. Caffo1, G. Tonazzolli2, G. Ambrosini1, F. Valduga1, C. Eccher2, A. Ferro1 & S. Forti2 1
Department of Medical Oncology, Santa Chiara Hospital; 2eHealth Applied Research Unit, FBK-irst, Fondazione Bruno Kessler, Trento, Italy
Received 18 February 2008; revised 18 July 2008; accepted 21 July 2008
Background: We describe our experience with an electronic oncological patient record (EOPR) for the total
introduction Despite impressive technological advances in healthcare over the last 20 years, patient records (PRs: the repository of patient history and the main support in clinical decision making) are still largely paper based. Many types of electronic PRs have been tried, but very few have become a routine part of total patient management and these vary widely between countries and specialties [1]. Information technology (IT) has therefore failed to achieve the same degree of penetration as it has in other fields, like the finance, transport, manufacturing and retail sectors, and we are still far from a paperless hospital [2–4]. A recent survey carried out by the Italian Ministry for Innovation and Technologies found that only 40% of healthcare organisations have adopted an IT system, mainly for administrative purposes, and a White Paper published by the Italian Association of Medical Oncology in 2004 reported 49.2% of 319 Medical Oncology Units were still using paper-
based PRs, 48.8% a mixed paper and electronic system and only 1.3% exclusively electronic PRs for the entire management of cancer patients [5]. Cancer is a highly complex disease that often presents alternating phases of tumour remission and progression and may require multiple therapeutic strategies involving different healthcare professionals. As suggested by the American Institute of Medicine, this complexity would greatly benefit from IT support to improve the timeliness and accuracy of information, as well as the quality of cancer care [6, 7]; however, the major challenge facing IT is managing the entire clinical course of single and multiple individual cancer patients. In June 1997, we began a 3-year project funded by the Italian Ministry of Health with the aim of designing, developing, adopting and evaluating a web-based electronic oncological patient record (EOPR) and teleconsultation module for the total management of cancer patients. This EOPR has been routinely used in our hospital since June 2000 [8–10].
methods *Correspondence to: Dr E. Galligioni, Department of Medical Oncology, Santa Chiara Hospital, Largo Medaglie d’Oro, 38100 Trento, Italy. Tel: +39-0461-903451; Fax: +39461-903364; E-mail: [email protected]
The EOPR, which was designed to allow rapid multipoint access to different users, was initially developed by combining the HTML web language with
ª The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected]
original article
training, followed by continuous assistance; user acceptance was monitored by means of three questionnaires administered after 2 weeks, 6 months and 6 years. Results: The EOPR has been used daily for all in-ward, day hospital and ambulatory clinical activities since July 2000. The most widely appreciated functions are its rapid multipoint access, the self-updated summary of the patients’ clinical course, the management of the entire therapeutic programme synchronised with working agendas and oncological teleconsultation. Security and privacy are assured by means of the separate storage of clinical and demographic data, with access protected by login and a password. The questionnaires highlighted appreciation of rapid data retrieval and exchange and the perception of improved quality of care, but also revealed a sense of additional work and a negative impact on doctor–patient relationships. Conclusions: Our EOPR has proved to be effective in the total management of cancer patients. Its user-centred design and flexible web technology have been key factors in its successful implementation and daily use. Key words: cancer patient management, digital record, electronic patient record
Downloaded from http://annonc.oxfordjournals.org/ at NERL on May 16, 2015
management of cancer patients.
Methods: The web-based EOPR was developed on the basis of a user-centred design including user education and
original article
results first prototype The preliminary investigation revealed different degrees of computer expertise among the users, who agreed to spend a limited time on data input. The task force therefore first tried to gain a detailed understanding of the care process by means of a step-by-step analysis of all clinical activities and the usual paper documentation. Data acquisition and retrieval were simplified by point and click interfaces and the use of radio buttons, check buttons and list boxes containing specific coded items. Free text fields were also allowed for relevant noncoded information. The major data and function sets were then defined and included:
Demographic data imported from the regional demographic database to avoid transcription errors and duplications. Anamnestic data, including risk factors, and past and recent medical history with chronic medications. Laboratory and instrumental data imported from the corresponding repositories, with the automatic highlighting of abnormal values. Pathological/clinical diagnosis based on the International Classification of Diseases for Oncology and tumour–node– metastasis system. Therapeutic programme, covering the entire process of care with the detailed doses, schedules, sequences and supportive drugs for all regimens. Therapies are proposed with automatic dose setting and updated sequencing (even in the case of dose modifications, treatment delays or integrated therapies), and cumulative drug doses and relative dose intensities are also automatically updated and recorded. Furthermore, all the therapies are traced with the names of the doctors and nurses and the date and time of prescription and administration.
350 | Galligioni et al.
A self-updated chronological summary of each patient’s clinical course, showing the sequence of different accesses, treatments, responses and toxic effects. Data are automatically extracted from any single patient’s access and grouped in a chronological order. Working agendas to arrange and synchronise patient appointments with the different clinical activities. Data extraction of clinical activities, patient and tumours characteristics, treatments and resource consumption, etc.
Once the core functions had been defined, different forms were designed for hospitalised, ambulatory and day hospital patients, to enable doctors and nurses to effectively manage patients in every situation. The corresponding doctors’ and nurses’ diaries were also implemented. The prototype underwent a long process of refinement by the task force, which used continuous interactive–iterative feedback to optimise the system architecture and user interface [17, 18].
system integration The EOPR initially designed for Medical Oncology was subsequently shared with the Radiotherapy Unit as a consequence of the strict interaction between units. For each patient, therefore, only one EOPR is available, implemented with specific forms, functionalities and agendas. Furthermore, other specialties (i.e. Surgery, Urology, Gynaecology, Head and Neck) were allowed to gain access to the EOPR for consultation. All relevant reports, particularly those of the multidisciplinary clinics, are imported in to the EOPR by the oncologists. Finally, the EOPR was made available to six peripheral hospitals, in which a limited oncological care is provided, to ensure a common tool for patient management and to be used for oncological teleconsultation, on specific problems, with the referral center in Trento. The teleconsultation is available with two modalities: the synchronous use of multipoint virtual meetings, supported by audio conferencing, synchronised surfing, interactive image sharing and chatting, and the asynchronous use of a patient-specific messaging service inside the EOPR work environment for short questions to and answers from a remote expert oncologist and for late medical reports. This experience, which has previously been partially reported [8, 19], will be the subject of a separate paper. privacy and security All unauthorised accesses to the EOPR are prevented by means of login and password controls associated with different profiles for doctors and nurses, each with specific permissions and limitations. To prevent the simultaneous entry of data relating to the same patient by different users, an internal lock is activated in order to restrict access for the compilation of a given EOPR to one user at a time. All accesses for data entry are recorded, with the date, time and user identification; similarly, any changes made to previous forms are traced after permanently saving the original data. Finally, the clinical and demographic data are stored separately
Volume 20 | No. 2 | February 2009
Downloaded from http://annonc.oxfordjournals.org/ at NERL on May 16, 2015
active server-side pages for the dynamic retrieving of clinical data from a Microsoft SQL Server database [7, 11]. In 2006, it was technologically revised: the graphic aspects of the user interface were entirely redesigned at presentation layer level and, at middle layer level, XML was adopted as data transportation format. This allows the clinical information contained in the EOPR to be easily mapped to the XML-based version of HL7 in order to enable data exchange with HL7compliant systems. At data layer level, the Oracle database was adopted. System development was on the basis of a user-centred design that allows end-users to influence the final product and how it takes shape [12–15]. A small task force of doctors, nurses and computer scientists analysed user requests and expectations in order to define the optimal data and function set [16] and, since its development, the prototype has been repeatedly revised in order to optimise the information content, system functions and the users’ interface. Before adopting the EOPR, the doctors and nurses were provided appropriate education and training, which was followed by on-site assistance during the initial routing and, subsequently, permanent remote assistance. User acceptance has been monitored by means of three anonymous questionnaires administered after 2 weeks, 6 months and 6 years of daily use. These questionnaires consisted of seven Likert scale statements, which were reduced to the three values of disagreement, agreement and neither in order to test for possible variations between periods.
Annals of Oncology
original article
Annals of Oncology
in the database, and the two types of information can only be correlated through the EOPR by means of an internal databinding mechanism.
user education and system roll out All the receivers attended two educational sessions aimed at clarifying the structure and functions of the EOPR, followed by training on practical simulation of new activities, both in the informatics laboratory and in working place. The doctors and nurses were trained separately in small groups, after their routine activities and the entire process required 3 months. After system adoption, users were further supported by the in-site assistance for 2 weeks, during the initial routing, and by the permanent remote assistance thereafter. The EOPR was introduced into everyday practice on 5 June 2000 for all new patients. To avoid a large unaffordable work, the existing paper-based records of previous patients were retained. EOPR was subsequently adopted also for previous patients, in case of relapse and, recently, for those still in follow-up. The number of patients entirely managed using the EOPR was therefore relatively small at the end of 2000 (566 patients), but this significantly increased by the end of 2007 to 13 878 patients, (with among others 3865 breast, 1819 colon, 1675 prostate and 1354 lung cancer patients), for a total of 130 006 different accesses. Presently, a printed copy of each EOPR is still available, for legal and regulatory purposes and for storage of paper data.
discussion We believe that the successful implementation and routine use of our EOPR over the last 7 years are due to a number of key factors. First of all, rapid multipoint access means that time is no longer taken up by searching for and retrieving records and, simultaneously, it is possible to undertake other activities, including multidisciplinary consultations and data
user satisfaction The answers to the first questionnaire, which was administered after 2 weeks of daily use, largely reflected the stress associated with the new operating procedures and the frequent requests
Table 1. Closed-response questions relating to user attitudes towards the system administered in two questionnaires 6 months (upper part of each statement row) and 6 years after system usage (lower part) Statement S1: intra- and interward information sharing and exchange have improved by using the system S2: the use of the system does not imply an additional workload S3: adoption of the system has favoured the standardisation of working procedures S4: adoption of the system has improved your professionalism S5: the quality of care has improved S6: the use of an IT system has made your relationships with patients more difficult S7: the use of an IT system makes it possible to obtain updated information concerning patient status
Responses Agree
Neither
Disagree
P
10 13 2 12 6 15 7 11 8 10 12 8 13 16
3 3 4 1 4 1 6 3 5 3 1 2 2 0
1 0 9 3 6 0 2 2 2 1 1 6 1 0
NS <0.01 <0.01 NS NS NS NS
To test possible differences between the short- and long-term, the Likert scale responses were reduced to three values: disagreement (1–3), agreement (5–7) and neither (4). v2 statistic of the resulting 2 · 3 contingency tables were used to test the null hypothesis of no changes in user attitudes, with a level of statistical significance of P = 0.01. NS, not significant.
Volume 20 | No. 2 | February 2009
doi:10.1093/annonc/mdn567 | 351
Downloaded from http://annonc.oxfordjournals.org/ at NERL on May 16, 2015
for on-site assistance. Users took an average of 2 months to become completely familiar with the EOPR. The second and the third questionnaires, which were administered in a more stable emotional phase, allow a better comparison of user opinions at different time points. Both questionnaires revealed a high degree of user motivation (86.6% and 100%), and the majority of users (100% and 88.2%) considered the EOPR reliable. In both the short- and the long term (Table 1), a large proportion of the doctors and nurses greatly appreciated the quick retrieval and exchange of updated information (S1, S7), together with the perception of professional growth (S4) and an improved quality of care (S5). A significant improvement in the standardisation of clinical and therapeutic procedures (S3) was more perceived after prolonged use in comparison with the first 6 months and, although the EOPR was considered a source of additional work by 53.4% of the users in the early phase (S2), this dropped to 17.7% 6 years later. A negative impact on doctor–patient relationships (S6) was reported by the majority of users in the early phase, and this only partially decreased in the longer term. However, taken together, both questionnaires indicated a good level of user satisfaction, with no differences between doctors and nurses.
original article
conclusions We believe that user involvement in the system design, flexible web technology, the development of appropriate functions for total patient management on the basis of clinicians’ needs and—last but not least—short- and long-term assistance are the key factors for successfully implementing and using a clinical IT system. Under these conditions, our EOPR has
352 | Galligioni et al.
proved to be effective for the total management of our cancer patients over the last 7 years. This will unable the measurement of any improvement of the quality of health care, on the basis of reliable and timely data.
funding The Italian Ministry of Health.
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extractions. Secondly, the complete and automatically updated summary of a patient’s clinical course (including treatments, responses and toxic effects) has greatly aided decision making, particularly when rapid decisions are required. Similarly, the management of the entire therapeutic programme, even in the case of different drug therapies (i.e. chemohormonal) or sequences (i.e. chemo A followed by chemo B) or integrated treatments (i.e. chemo + radio or chemo + surgery), has offered fundamental support. All appointments are automatically synchronised with the corresponding agendas and updated in the case of delays due to toxicity or other reasons, and all dose reductions or treatment modifications are proposed at the subsequent cycle in order to confirm or modify changes. Furthermore, the full traceability of all drug prescriptions and administrations has reduced clinical risk and likely improved the quality of care. Similarly, the automatic predisposition of letters and other forms has led to greater accuracy and significant time savings. Finally, the profound integration of EOPR functionalities has enabled professionals to monitor major clinical activities and resource consumption, matched against different tumours and different treatments. It is well known that it is often difficult to adopt new technologies in structured organisations like hospital units, but the user-centred design of our EOPR, and the education, training and continuous assistance provided, have greatly facilitated end-user acceptance, as is shown by the prevalence of positive responses to the questionnaires. Furthermore, any IT implementation clearly requires full integration with other hospital information systems in order to be able to exchange and share information with other diagnostic, therapeutic and administrative units, as well as with other hospitals, and this must always be considered from the beginning. In this context, web technologies and XML were the necessary fundamentals of our EOPR, which can easily be integrated with any HL7-compliant system [20]. As far as costs are concerned, the hardware includes a personal computer for every doctor and nurse working station, but these are now widely available in most hospitals and their cost has been continuously decreasing. Software costs obviously depend on the market and specific local requirements but, whatever the choice, they must include long-term assistance, which should also provide for system updating and personalisation on the basis of local needs.
Annals of Oncology