Telemedicine Spirometry Training and Quality Assurance Program in Primary Care Centers of a Public Health System
Nuria Marina Malanda, BM,1 Elena Lo´pez de Santa Marı´a, BN,1 Asuncio´n Gutie´rrez, MBA,2 Juan Carlos Bayo´n, MEcon,2 Larraitz Garcia, BM,1 and Juan B. Ga´ldiz, PhD1,3,4 1
Respiratory Function Laboratory, Department of Pulmonology, Cruces University Hospital, Barakaldo, Bizkaia, Spain. 2 Service Health Technology Assessment of the Basque Country, Department of Health, Basque Government, Vitoria, Spain. 3 Network Research Center of Respiratory Diseases, Barakaldo, Bizkaia, Spain. 4 University of the Basque Country, Barakaldo, Bizkaia, Spain.
Abstract Background: Forced spirometry is essential for diagnosing respiratory diseases and is widely used across levels of care. However, several studies have shown that spirometry quality in primary care is not ideal, with risks of misdiagnosis. Our objective was to assess the feasibility and performance of a telemedicine-based training and quality assurance program for forced spirometry in primary care. Materials and Methods: The two phases included (1) a 9-month pilot study involving 15 centers, in which spirometry tests were assessed by the Basque Office for Health Technology Assessment, and (2) the introduction of the program to all centers in the Public Basque Health Service. Technicians first received 4 h of training, and, subsequently, they sent all tests to the reference laboratory using the program. Quality assessment was performed in accordance with clinical guidelines (A and B, good; C–F, poor). Results: In the first phase, 1,894 spirometry tests were assessed, showing an improvement in quality: acceptable quality tests increased from 57% at the beginning to 78% after 6 months and 83% after 9 months (p < 0.001). In the second phase, 7,200 spirometry tests were assessed after the inclusion of 36 additional centers, maintaining the positive trend (61%, 87%, and 84% at the same time points; p < 0.001). Conclusions: (1) The quality of spirometry tests improved in all centers. (2) The program provides a tool for transferring data that allows monitoring of its quality and training of technicians who perform the tests. (3) This approach is useful for improving spirometry quality in the routine practice of a public health system. Key words: telemedicine, telehealth, distance learning
Introduction
F
orced spirometry (FS) is the first-line diagnostic procedure for patients with respiratory symptoms because it can be key to diagnosing obstructive pulmonary diseases.1–4 Until recently, FS was almost only used in hospitals and in pulmonology
388 TELEMEDICINE and e-HEALTH A P R I L 2 0 1 4
departments by technicians who had received specific training. Nowadays, the test has been extended to primary care (PC), and, with this, quality control has become a challenging issue, given the number of technicians and organizational models involved. The quality of FS is highly dependent on the skills of the technician. In relation to this, the guidelines of pulmonology societies5–7 indicate the need for a training period, under supervision, to develop the skills necessary for carrying out this test. Several studies have surveyed the quality of FS tests in PC settings and have exposed a lack of qualified personnel and an overall underuse of these tests.8–11 It has been demonstrated that it is important to have a quality assurance program to achieve good outcomes, with feedback and support for the operating technicians to address any doubts and queries as they arise.6 It is notable that FS is an essential tool for the diagnosis of several respiratory diseases that are highly prevalent, such as chronic obstructive pulmonary disease (COPD) and asthma. It is very important that it is performed and used correctly12 to avoid incorrect diagnoses. In our setting, this is of considerable clinical relevance because COPD has a prevalence of around 9% in 40–69 year olds, and as many as 78.2% of cases detected in recent research had not been diagnosed prior to the study,13 indicating that COPD is both highly prevalent and widely underdiagnosed.14 Moreover, respiratory disorders represent a considerable economic burden.14,15 Recently, strategies have been proposed recommending the use of telemedicine-based monitoring systems for spirometry quality assurance in various settings.16–21 Members of our research group (Burgos et al.19) have demonstrated that telemedicine systems can have a positive impact on the quality of this testing. In this context, various studies22–24 have focused on the need to extend training programs from pulmonary function laboratories to primary health centers to improve the quality. The objective of this study was to evaluate the feasibility and performance of an online training and quality assurance program for spirometry in a PC setting in a public health system.
Materials and Methods This was a prospective and longitudinal study, which was divided into two phases. The first phase was a 9-month study to assess the efficacy of an FS quality assurance program for implementation and interpretation of tests carried out by nursing staff in PC. We assessed all the tests performed by nurses within routine clinical practice in 15 selected health centers, to assess the efficacy of this new way of working. The public Basque Health Service (Osakidetza) requested a pilot study to evaluate the performance of this intervention in order to decide whether to introduce it to its portfolio of
DOI: 10.1089/tmj.2013.0111
TELEMEDICINE SPIROMETRY QUALITY ASSURANCE PROGRAM
services. On this basis, this pilot study was funded and evaluated by the Basque Office for Health Technology Assessment (Osteba).25 The second phase is the introduction of this program to all health centers, and it is expected to be rolled out across the entire healthcare network in 2014–2015. To date, the program has been set up in 51 health centers (36 new centers having been included), in all of which the software is used in routine clinical practice, and these are the centers analyzed in this study.
DESCRIPTION OF THE COMPUTER SOFTWARE Our collaboration with previous telemedicine projects19 provided us with the experience to develop a new software program, e-Spiro (technical support from Linkcare Health Services). With clinical data being sent in a standard format, using Health Level 7 version 3 clinical document architecture, release 2, the system provides the technology to allow the remote monitoring of spirometry quality for an unlimited number of health centers. An Oracle (Redwood City, CA) driver was used for the database, the hardware platform, and the Microsoft (Redmond, WA) Windows server. The system provides the infrastructure for spirometry data to be accessed from all care levels and, at the same time, is a key technical tool for spirometry quality assurance programs.26,27 The software runs across a network of nodes, each corresponding to a local health center that operates independently and has several technicians (two to four) who perform the test (Fig. 1). In the program, three profiles are defined: (1) the administrator, who manages the users of the program, the centers, and types of spirometers; (2) the coordinator, a pulmonologist, who is responsible for evaluating and grading the spirometry tests, on the basis of the curves and data entered; and (3) the technician, who is responsible for
managing the patients, performing the FS tests, and, subsequently, uploading the data to the server. All of these people have passwords to log-in to the program. The software has the following functions: it sends spirometer outputs, curves, and numerical data from the external centers to the coordinator and returns the checked test and assessment feedback to the technicians. Currently, the software is compatible with several brands of spirometer: Datospir (110, 120, and Micro C; Sibelmed, Barcelona, Spain) and EasyOne (NDD Medical Technologies, Andover, MA), both of which have been validated by scientific societies.5,7,28 It would, however, be possible to add other models at the request of a user. These spirometers generate .xml files of the numerical data and of the spirometer curves. Once these files have been sent to the server by the technician, the coordinator can access them and assess the test. This assessment consists of a technical description of the spirometry data, including the shapes of the volume–time and flow–volume curves, in accordance with the guidelines.6,7,29,30 In cases where the quality is not good, the coordinator adds a description of the errors to which the poor quality can be attributed and advice on improving the performance of the test, thereby providing ongoing training. On the other hand, if the test is judged to be of good quality, a pulmonary function report is added to the FS data, addressed to the PC physician responsible for the patient. After each test has been assessed, the software generates and archives a .pdf version of the report.
RECRUITMENT OF HEALTH CENTERS To guide the recruitment of health centers, we requested information about the health professionals and the availability of spirometers from the supervisors in charge of each region. We decided to start with two to four users per center. In this first phase, lasting 9 months, we recruited 15 primary health centers (33 users), whereas in the second phase, with the rolling out of the system across the public health system, 36 more health centers (75 users) have completed 9 months of training (at the time of writing this article). We decided to assess the quality of the tests after 6 and 9 months given that the guidelines of the Spanish Society of Pulmonology indicate 6 months as the minimum period of training required to perform FS,5 whereas data at 9 months should serve to verify trends in test quality and training.
TRAINING OF PROFESSIONALS
Fig. 1. Organizational chart of the computer program, with three defined roles: administrator, coordinator, and technician. At present, 202 technicians have been trained in 83 health centers covering a population of over a million. PC, primary care.
ª M A R Y A N N L I E B E R T , I N C . VOL. 20
This consisted of a 4-h practical training session, covering background on the spirometry test and quality criteria according to the practice guidelines for pulmonary medicine,5–7,29,30 as well as use of the computer program and spirometer. This session was run in each PC center for the health professionals who were to be responsible for performing the tests. After this training, the
NO. 4 APRIL 2014
TELEMEDICINE and e-HEALTH 389
MARINA MALANDA ET AL.
Table 1. Spirometry Quality Control Grades QUALITY GRADE A
DESCRIPTION Three acceptable spirograms, with two of these being reproducible (with differences in FEV1 and FVC between the best two of
Nuria Marina Malanda, BM,1 Elena Lo´pez de Santa Marı´a, BN,1 Asuncio´n Gutie´rrez, MBA,2 Juan Carlos Bayo´n, MEcon,2 Larraitz Garcia, BM,1 and Juan B. Ga´ldiz, PhD1,3,4 1
Respiratory Function Laboratory, Department of Pulmonology, Cruces University Hospital, Barakaldo, Bizkaia, Spain. 2 Service Health Technology Assessment of the Basque Country, Department of Health, Basque Government, Vitoria, Spain. 3 Network Research Center of Respiratory Diseases, Barakaldo, Bizkaia, Spain. 4 University of the Basque Country, Barakaldo, Bizkaia, Spain.
Abstract Background: Forced spirometry is essential for diagnosing respiratory diseases and is widely used across levels of care. However, several studies have shown that spirometry quality in primary care is not ideal, with risks of misdiagnosis. Our objective was to assess the feasibility and performance of a telemedicine-based training and quality assurance program for forced spirometry in primary care. Materials and Methods: The two phases included (1) a 9-month pilot study involving 15 centers, in which spirometry tests were assessed by the Basque Office for Health Technology Assessment, and (2) the introduction of the program to all centers in the Public Basque Health Service. Technicians first received 4 h of training, and, subsequently, they sent all tests to the reference laboratory using the program. Quality assessment was performed in accordance with clinical guidelines (A and B, good; C–F, poor). Results: In the first phase, 1,894 spirometry tests were assessed, showing an improvement in quality: acceptable quality tests increased from 57% at the beginning to 78% after 6 months and 83% after 9 months (p < 0.001). In the second phase, 7,200 spirometry tests were assessed after the inclusion of 36 additional centers, maintaining the positive trend (61%, 87%, and 84% at the same time points; p < 0.001). Conclusions: (1) The quality of spirometry tests improved in all centers. (2) The program provides a tool for transferring data that allows monitoring of its quality and training of technicians who perform the tests. (3) This approach is useful for improving spirometry quality in the routine practice of a public health system. Key words: telemedicine, telehealth, distance learning
Introduction
F
orced spirometry (FS) is the first-line diagnostic procedure for patients with respiratory symptoms because it can be key to diagnosing obstructive pulmonary diseases.1–4 Until recently, FS was almost only used in hospitals and in pulmonology
388 TELEMEDICINE and e-HEALTH A P R I L 2 0 1 4
departments by technicians who had received specific training. Nowadays, the test has been extended to primary care (PC), and, with this, quality control has become a challenging issue, given the number of technicians and organizational models involved. The quality of FS is highly dependent on the skills of the technician. In relation to this, the guidelines of pulmonology societies5–7 indicate the need for a training period, under supervision, to develop the skills necessary for carrying out this test. Several studies have surveyed the quality of FS tests in PC settings and have exposed a lack of qualified personnel and an overall underuse of these tests.8–11 It has been demonstrated that it is important to have a quality assurance program to achieve good outcomes, with feedback and support for the operating technicians to address any doubts and queries as they arise.6 It is notable that FS is an essential tool for the diagnosis of several respiratory diseases that are highly prevalent, such as chronic obstructive pulmonary disease (COPD) and asthma. It is very important that it is performed and used correctly12 to avoid incorrect diagnoses. In our setting, this is of considerable clinical relevance because COPD has a prevalence of around 9% in 40–69 year olds, and as many as 78.2% of cases detected in recent research had not been diagnosed prior to the study,13 indicating that COPD is both highly prevalent and widely underdiagnosed.14 Moreover, respiratory disorders represent a considerable economic burden.14,15 Recently, strategies have been proposed recommending the use of telemedicine-based monitoring systems for spirometry quality assurance in various settings.16–21 Members of our research group (Burgos et al.19) have demonstrated that telemedicine systems can have a positive impact on the quality of this testing. In this context, various studies22–24 have focused on the need to extend training programs from pulmonary function laboratories to primary health centers to improve the quality. The objective of this study was to evaluate the feasibility and performance of an online training and quality assurance program for spirometry in a PC setting in a public health system.
Materials and Methods This was a prospective and longitudinal study, which was divided into two phases. The first phase was a 9-month study to assess the efficacy of an FS quality assurance program for implementation and interpretation of tests carried out by nursing staff in PC. We assessed all the tests performed by nurses within routine clinical practice in 15 selected health centers, to assess the efficacy of this new way of working. The public Basque Health Service (Osakidetza) requested a pilot study to evaluate the performance of this intervention in order to decide whether to introduce it to its portfolio of
DOI: 10.1089/tmj.2013.0111
TELEMEDICINE SPIROMETRY QUALITY ASSURANCE PROGRAM
services. On this basis, this pilot study was funded and evaluated by the Basque Office for Health Technology Assessment (Osteba).25 The second phase is the introduction of this program to all health centers, and it is expected to be rolled out across the entire healthcare network in 2014–2015. To date, the program has been set up in 51 health centers (36 new centers having been included), in all of which the software is used in routine clinical practice, and these are the centers analyzed in this study.
DESCRIPTION OF THE COMPUTER SOFTWARE Our collaboration with previous telemedicine projects19 provided us with the experience to develop a new software program, e-Spiro (technical support from Linkcare Health Services). With clinical data being sent in a standard format, using Health Level 7 version 3 clinical document architecture, release 2, the system provides the technology to allow the remote monitoring of spirometry quality for an unlimited number of health centers. An Oracle (Redwood City, CA) driver was used for the database, the hardware platform, and the Microsoft (Redmond, WA) Windows server. The system provides the infrastructure for spirometry data to be accessed from all care levels and, at the same time, is a key technical tool for spirometry quality assurance programs.26,27 The software runs across a network of nodes, each corresponding to a local health center that operates independently and has several technicians (two to four) who perform the test (Fig. 1). In the program, three profiles are defined: (1) the administrator, who manages the users of the program, the centers, and types of spirometers; (2) the coordinator, a pulmonologist, who is responsible for evaluating and grading the spirometry tests, on the basis of the curves and data entered; and (3) the technician, who is responsible for
managing the patients, performing the FS tests, and, subsequently, uploading the data to the server. All of these people have passwords to log-in to the program. The software has the following functions: it sends spirometer outputs, curves, and numerical data from the external centers to the coordinator and returns the checked test and assessment feedback to the technicians. Currently, the software is compatible with several brands of spirometer: Datospir (110, 120, and Micro C; Sibelmed, Barcelona, Spain) and EasyOne (NDD Medical Technologies, Andover, MA), both of which have been validated by scientific societies.5,7,28 It would, however, be possible to add other models at the request of a user. These spirometers generate .xml files of the numerical data and of the spirometer curves. Once these files have been sent to the server by the technician, the coordinator can access them and assess the test. This assessment consists of a technical description of the spirometry data, including the shapes of the volume–time and flow–volume curves, in accordance with the guidelines.6,7,29,30 In cases where the quality is not good, the coordinator adds a description of the errors to which the poor quality can be attributed and advice on improving the performance of the test, thereby providing ongoing training. On the other hand, if the test is judged to be of good quality, a pulmonary function report is added to the FS data, addressed to the PC physician responsible for the patient. After each test has been assessed, the software generates and archives a .pdf version of the report.
RECRUITMENT OF HEALTH CENTERS To guide the recruitment of health centers, we requested information about the health professionals and the availability of spirometers from the supervisors in charge of each region. We decided to start with two to four users per center. In this first phase, lasting 9 months, we recruited 15 primary health centers (33 users), whereas in the second phase, with the rolling out of the system across the public health system, 36 more health centers (75 users) have completed 9 months of training (at the time of writing this article). We decided to assess the quality of the tests after 6 and 9 months given that the guidelines of the Spanish Society of Pulmonology indicate 6 months as the minimum period of training required to perform FS,5 whereas data at 9 months should serve to verify trends in test quality and training.
TRAINING OF PROFESSIONALS
Fig. 1. Organizational chart of the computer program, with three defined roles: administrator, coordinator, and technician. At present, 202 technicians have been trained in 83 health centers covering a population of over a million. PC, primary care.
ª M A R Y A N N L I E B E R T , I N C . VOL. 20
This consisted of a 4-h practical training session, covering background on the spirometry test and quality criteria according to the practice guidelines for pulmonary medicine,5–7,29,30 as well as use of the computer program and spirometer. This session was run in each PC center for the health professionals who were to be responsible for performing the tests. After this training, the
NO. 4 APRIL 2014
TELEMEDICINE and e-HEALTH 389
MARINA MALANDA ET AL.
Table 1. Spirometry Quality Control Grades QUALITY GRADE A
DESCRIPTION Three acceptable spirograms, with two of these being reproducible (with differences in FEV1 and FVC between the best two of
