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1.  Involving service users in trials: developing a standard operating procedure 
Trials  2013;14:219.
Background
Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We aimed to develop a standard operating procedure (SOP) to support researchers to involve service users in trials and rigorous studies.
Methods
Researchers with experience of involving service users and service users who were contributing to trials collaborated with the West Wales Organisation for Rigorous Trials in Health, a registered clinical trials unit, to develop the SOP. Drafts were prepared in a Task and Finish Group, reviewed by all co-authors and amendments made.
Results
We articulated core principles, which defined equality of service users with all other research team members and collaborative processes underpinning the SOP, plus guidance on how to achieve these. We developed a framework for involving service users in research that defined minimum levels of collaboration plus additional consultation and decision-making opportunities. We recommended service users be involved throughout the life of a trial, including planning and development, data collection, analysis and dissemination, and listed tasks for collaboration. We listed people responsible for involving service users in studies and promoting an inclusive culture. We advocate actively involving service users as early as possible in the research process, with a minimum of two on all formal trial groups and committees. We propose that researchers protect at least 1% of their total research budget as a minimum resource to involve service users and allow enough time to facilitate active involvement.
Conclusions
This SOP provides guidance to researchers to involve service users successfully in developing and conducting clinical trials and creating a culture of actively involving service users in research at all stages. The UK Clinical Research Collaboration should encourage clinical trials units actively to involve service users and research funders should provide sufficient funds and time for this in research grants.
doi:10.1186/1745-6215-14-219
PMCID: PMC3725161  PMID: 23866730
Consumer participation; Consumer involvement; Clinical trials; Service user involvement
2.  The role of the user within the medical device design and development process: medical device manufacturers' perspectives 
Background
Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so.
Methods
In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process.
Results
A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process.
Conclusions
Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised.
doi:10.1186/1472-6947-11-15
PMCID: PMC3058010  PMID: 21356097
3.  HIN9/468: The Last Mile - Secure and mobile data processing in healthcare 
Motivation
According to the Federal Ministry the avowed target of modern medicine is to administer the best medical care, the newest scientific insights and the knowledge of experienced specialists on affordable conditions to every patient no matter whether he is located in a rural area or in a teaching hospital. One way of administer information is on mobile tools. To find out more about the influence of mobile computer on the physician-patient relation, the acceptance of these tools as well as prerequisites of new security and data-processing concepts were investigated in a simulation study.
Methods
The Personal Digital Assistant
Based on a personal digital assistant a prototype was developed. The Apple Newton was used because it appeared suitable for easy data input and retrieval by the means of a touch screen with handwriting recognition. The device was coupled with a conventional cellular phone for voice and data transfer The prototype provided several functions for information processing:
access to a patient database
access to medical knowledge
documentation of diagnosis
electronic requests forms for investigations
tools for the personal organization.
The prototype of an accessibility and safety manager was integrated. This software enables to control telephone accessibility individually. Situational adjustments and a complex set of rules configured the way arriving calls were dealt with. Moreover this software contained a component for sending and receiving text messages.
The Simulation Study
In simulation studies, test users are observed while working with prototypical technology in a close-to-reality environment. The aim is to test an early prototype in its avowed environment to obtain design proposals for technology by the future users. Within the Ladenburger group "Security in communications technology" of the Gottlieb-Daimler und Karl-Benz-Stiftung an investigation at the Heidelberg University Medical Centre was conducted under organisational management of the project group "Verfassungsverträgliche Technikgestaltung (Provet)". Thirty-one health professionals tested the device described above. Data about the user experience were obtained by:
observation while using the device
evening meeting with main topic
structured questionnaire
individual interview
Results
After the investigation week more than 2/3 of the participants indicated that they expect no or a positive modification of their communication behaviour. To emphasise is a group of test persons (one out of five), who feared a negative modification of their communication behaviour. Mobile data processing was judged as important and useful by more than two third of the professionals asked.
Conclusions
At present the original concept of a multifunctional device with integration of mobile voice and data communication did not prove as practicable. Rather a multi-device concept with stationary, mobile and hand-held device has to be developed.
doi:10.2196/jmir.1.suppl1.e40
PMCID: PMC1761797
Mobile Computing; Technology Assessment; Clinical Information Systems
4.  Facebook for Scientists: Requirements and Services for Optimizing How Scientific Collaborations Are Established 
Background
As biomedical research projects become increasingly interdisciplinary and complex, collaboration with appropriate individuals, teams, and institutions becomes ever more crucial to project success. While social networks are extremely important in determining how scientific collaborations are formed, social networking technologies have not yet been studied as a tool to help form scientific collaborations. Many currently emerging expertise locating systems include social networking technologies, but it is unclear whether they make the process of finding collaborators more efficient and effective.
Objective
This study was conducted to answer the following questions: (1) Which requirements should systems for finding collaborators in biomedical science fulfill? and (2) Which information technology services can address these requirements?
Methods
The background research phase encompassed a thorough review of the literature, affinity diagramming, contextual inquiry, and semistructured interviews. This phase yielded five themes suggestive of requirements for systems to support the formation of collaborations. In the next phase, the generative phase, we brainstormed and selected design ideas for formal concept validation with end users. Then, three related, well-validated ideas were selected for implementation and evaluation in a prototype.
Results
Five main themes of systems requirements emerged: (1) beyond expertise, successful collaborations require compatibility with respect to personality, work style, productivity, and many other factors (compatibility); (2) finding appropriate collaborators requires the ability to effectively search in domains other than your own using information that is comprehensive and descriptive (communication); (3) social networks are important for finding potential collaborators, assessing their suitability and compatibility, and establishing contact with them (intermediation); (4) information profiles must be complete, correct, up-to-date, and comprehensive and allow fine-grained control over access to information by different audiences (information quality and access); (5) keeping online profiles up-to-date should require little or no effort and be integrated into the scientist’s existing workflow (motivation). Based on the requirements, 16 design ideas underwent formal validation with end users. Of those, three were chosen to be implemented and evaluated in a system prototype, “Digital|Vita”: maintaining, formatting, and semi-automated updating of biographical information; searching for experts; and building and maintaining the social network and managing document flow.
Conclusions
In addition to quantitative and factual information about potential collaborators, social connectedness, personal and professional compatibility, and power differentials also influence whether collaborations are formed. Current systems only partially model these requirements. Services in Digital|Vita combine an existing workflow, maintaining and formatting biographical information, with collaboration-searching functions in a novel way. Several barriers to the adoption of systems such as Digital|Vita exist, such as potential adoption asymmetries between junior and senior researchers and the tension between public and private information. Developers and researchers may consider one or more of the services described in this paper for implementation in their own expertise locating systems.
doi:10.2196/jmir.1047
PMCID: PMC2553246  PMID: 18701421
Expertise locating systems; computer supported collaborative work; information systems; collaborators; research; social networks; translational research
5.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
6.  Experiences of Multidisciplinary Development Team Members During User-Centered Design of Telecare Products and Services: A Qualitative Study 
Background
User-centered design (UCD) methodologies can help take the needs and requirements of potential end-users into account during the development of innovative telecare products and services. Understanding how members of multidisciplinary development teams experience the UCD process might help to gain insight into factors that members with different backgrounds consider critical during the development of telecare products and services.
Objective
The primary objective of this study was to explore how members of multidisciplinary development teams experienced the UCD process of telecare products and services. The secondary objective was to identify differences and similarities in the barriers and facilitators they experienced.
Methods
Twenty-five members of multidisciplinary development teams of four Research and Development (R&D) projects participated in this study. The R&D projects aimed to develop telecare products and services that can support self-management in elderly people or patients with chronic conditions. Seven participants were representatives of end-users (elderly persons or patients with chronic conditions), three were professional end-users (geriatrician and nurses), five were engineers, four were managers (of R&D companies or engineering teams), and six were researchers. All participants were interviewed by a researcher who was not part of their own development team. The following topics were discussed during the interviews: (1) aim of the project, (2) role of the participant, (3) experiences during the development process, (4) points of improvement, and (5) what the project meant to the participant.
Results
Experiences of participants related to the following themes: (1) creating a development team, (2) expectations regarding responsibilities and roles, (3) translating user requirements into technical requirements, (4) technical challenges, (5) evaluation of developed products and services, and (6) valorization. Multidisciplinary team members from different backgrounds often reported similar experienced barriers (eg, different members of the development team speak a “different language”) and facilitators (eg, team members should voice expectations at the start of the project to prevent miscommunication at a later stage). However, some experienced barriers and facilitators were reported only by certain groups of participants. For example, only managers reported the experience that having different ideas about what a good business case is within one development team was a barrier, whereas only end-users emphasized the facilitating role of project management in end-user participation and the importance of continuous feedback from researchers on input of end-users.
Conclusions
Many similarities seem to exist between the experienced barriers and facilitators of members of multidisciplinary development teams during UCD of telecare products and services. However, differences in experiences between team members from various backgrounds exist as well. Insights into these similarities and differences can improve understanding between team members from different backgrounds, which can optimize collaboration during the development of telecare products and services.
doi:10.2196/jmir.3195
PMCID: PMC4051739  PMID: 24840245
user-centered design; telecare; eHealth; participation; multidisciplinary team; barriers and facilitators
7.  Evaluation of User Interface and Workflow Design of a Bedside Nursing Clinical Decision Support System 
Background
Clinical decision support systems (CDSS) are important tools to improve health care outcomes and reduce preventable medical adverse events. However, the effectiveness and success of CDSS depend on their implementation context and usability in complex health care settings. As a result, usability design and validation, especially in real world clinical settings, are crucial aspects of successful CDSS implementations.
Objective
Our objective was to develop a novel CDSS to help frontline nurses better manage critical symptom changes in hospitalized patients, hence reducing preventable failure to rescue cases. A robust user interface and implementation strategy that fit into existing workflows was key for the success of the CDSS.
Methods
Guided by a formal usability evaluation framework, UFuRT (user, function, representation, and task analysis), we developed a high-level specification of the product that captures key usability requirements and is flexible to implement. We interviewed users of the proposed CDSS to identify requirements, listed functions, and operations the system must perform. We then designed visual and workflow representations of the product to perform the operations. The user interface and workflow design were evaluated via heuristic and end user performance evaluation. The heuristic evaluation was done after the first prototype, and its results were incorporated into the product before the end user evaluation was conducted. First, we recruited 4 evaluators with strong domain expertise to study the initial prototype. Heuristic violations were coded and rated for severity. Second, after development of the system, we assembled a panel of nurses, consisting of 3 licensed vocational nurses and 7 registered nurses, to evaluate the user interface and workflow via simulated use cases. We recorded whether each session was successfully completed and its completion time. Each nurse was asked to use the National Aeronautics and Space Administration (NASA) Task Load Index to self-evaluate the amount of cognitive and physical burden associated with using the device.
Results
A total of 83 heuristic violations were identified in the studies. The distribution of the heuristic violations and their average severity are reported. The nurse evaluators successfully completed all 30 sessions of the performance evaluations. All nurses were able to use the device after a single training session. On average, the nurses took 111 seconds (SD 30 seconds) to complete the simulated task. The NASA Task Load Index results indicated that the work overhead on the nurses was low. In fact, most of the burden measures were consistent with zero. The only potentially significant burden was temporal demand, which was consistent with the primary use case of the tool.
Conclusions
The evaluation has shown that our design was functional and met the requirements demanded by the nurses’ tight schedules and heavy workloads. The user interface embedded in the tool provided compelling utility to the nurse with minimal distraction.
doi:10.2196/ijmr.2402
PMCID: PMC3628119  PMID: 23612350
clinical decision support systems; user-computer interface; software design; human computer interaction; usability testing; heuristic evaluations; software performance; patient-centered care
8.  Transferring patients to tertiary health care: the role of family and Primary Health Care Teams 
Purpose
One of the main problems of health systems is to ensure access and proper coordination between different health services. This problem is particularly felt when a patient is transferred from one level to another, especially for long-term care.
Therefore, it is essential to develop new organizational models, which should meet user’s need. The primary Health Care (PHC) within the current Portuguese Primary Health Care Reform (PPHCR) could develop an important role, due to intrinsic innovative aspects associated with new governance model based on the development of a small family health multi-professional unit (USF) with functional and technical autonomy, integrated within a network with other functional units and the establishment of Health Center Clusters, producing meaningful healthcare delivered value.
Theory
Grounded on the health services utilization model of Dutton (1986) and on multidisciplinary assessment and decision-making model of Beckingham and Baumann (1990) for ageing families.
Research question
In the PPHCR context, how families experience the decision-making process of transferring an elderly relative with dementia?
Research method
An exploratory case study, with two embedded units of analysis (Ying 2003): families of the elderly with dementia and primary health care teams, Data were collected through semi-structured interviews and focus group. The data analysis was achieved through thematic content analysis (Bardin 2008) and descriptive statistical analysis with the support of computer program SPSS. See Figure 1 for the conceptual research model.
Results
Families who had shared their decision-making process with health care teams, recognize their fundamental role as mediator between the families and the complexity of the health and social system. The families, who had been followed up by the Primary Health Care Teams (PHCT), were more satisfied with their decision. However, there still exist some difficulties to address in order to benefit from a more integrated care:
The communication between the different functional health units and health and social professionals is sometimes inadequate, with gaps, causing delays in response time, especially in crisis situations;
Misunderstood and overlap competencies among team members;
Different interpretations of referrals practices and clinical criteria to transferring patients.
Restrict use of new technologies.
Conclusions
The PPHCR has been an opportunity to create innovation in healthcare delivering value, which is recognized through the families who had been accompanied by the Primary Health Care Teams. However, there still exist some problems, mainly associated to team-work, communication and the use of new technologies. To achieve an innovation culture of excellence it is fundamental the development by PHCT of integration competences and the capacity to introduce project-based approaches that would foster collaboration initiatives.
Discussion
What are the key integration competences that PHCT must domain?How can we measured the degree of health care delivery integration?
PMCID: PMC3617763
integration competences; integrated care; health care delivery; primary health care; governance
9.  Achieving Continuity of Care: Facilitators and Barriers in Community Mental Health Teams 
Background
The integration of mental health and social services for people diagnosed with severe mental illness (SMI) has been a key aspect of attempts to reform mental health services in the UK and aims to minimise user and carer distress and confusion arising from service discontinuities. Community mental health teams (CMHTs) are a key component of UK policy for integrated service delivery, but implementing this policy has raised considerable organisational challenges. The aim of this study was to identify and explore facilitators and barriers perceived to influence continuity of care by health and social care professionals working in and closely associated with CMHTs.
Methods
This study employed a survey design utilising in-depth, semi-structured interviews with a proportionate, random sample of 113 health and social care professionals and representatives of voluntary organisations. Participants worked in two NHS Mental Health Trusts in greater London within eight adult CMHTs and their associated acute in-patient wards, six local general practices, and two voluntary organisations.
Results
Team leadership, decision making, and experiences of teamwork support were facilitators for cross boundary and team continuity; face-to-face communication between teams, managers, general practitioners, and the voluntary sector were facilitators for information continuity. Relational, personal, and longitudinal continuity were facilitated in some local areas by workforce stability. Barriers for cross boundary and team continuity were specific leadership styles and models of decision making, blurred professional role boundaries, generic working, and lack of training for role development. Barriers for relational, personal, and longitudinal continuity were created by inadequate staffing levels, high caseloads, and administrative duties that could limit time spent with users. Incompatibility of information technology systems hindered information continuity. Flexible continuity was challenged by the increasingly complex needs of service users.
Conclusions
Substantive challenges exist in harnessing the benefits of integrated CMHT working to deliver continuity of care. Team support should be prioritised in terms of IT provision linked to a review of current models of administrative support. Investment in education and training for role development, leadership, workforce retention, and skills to meet service users' complex needs are recommended.
doi:10.1186/1748-5908-6-23
PMCID: PMC3073925  PMID: 21418579
10.  Use of contextual inquiry to understand anatomic pathology workflow: Implications for digital pathology adoption 
Background:
For decades anatomic pathology (AP) workflow have been a highly manual process based on the use of an optical microscope and glass slides. Recent innovations in scanning and digitizing of entire glass slides are accelerating a move toward widespread adoption and implementation of a workflow based on digital slides and their supporting information management software. To support the design of digital pathology systems and ensure their adoption into pathology practice, the needs of the main users within the AP workflow, the pathologists, should be identified. Contextual inquiry is a qualitative, user-centered, social method designed to identify and understand users’ needs and is utilized for collecting, interpreting, and aggregating in-detail aspects of work.
Objective:
Contextual inquiry was utilized to document current AP workflow, identify processes that may benefit from the introduction of digital pathology systems, and establish design requirements for digital pathology systems that will meet pathologists’ needs.
Materials and Methods:
Pathologists were observed and interviewed at a large academic medical center according to contextual inquiry guidelines established by Holtzblatt et al. 1998. Notes representing user-provided data were documented during observation sessions. An affinity diagram, a hierarchal organization of the notes based on common themes in the data, was created. Five graphical models were developed to help visualize the data including sequence, flow, artifact, physical, and cultural models.
Results:
A total of six pathologists were observed by a team of two researchers. A total of 254 affinity notes were documented and organized using a system based on topical hierarchy, including 75 third-level, 24 second-level, and five main-level categories, including technology, communication, synthesis/preparation, organization, and workflow. Current AP workflow was labor intensive and lacked scalability. A large number of processes that may possibly improve following the introduction of digital pathology systems were identified. These work processes included case management, case examination and review, and final case reporting. Furthermore, a digital slide system should integrate with the anatomic pathologic laboratory information system.
Conclusions:
To our knowledge, this is the first study that utilized the contextual inquiry method to document AP workflow. Findings were used to establish key requirements for the design of digital pathology systems.
doi:10.4103/2153-3539.101794
PMCID: PMC3519008  PMID: 23243553
Anatomic pathology; contextual inquiry; workflow; digital pathology
11.  Developing Internet-Based Health Interventions: A Guide for Public Health Researchers and Practitioners 
Background
Researchers and practitioners interested in developing online health interventions most often rely on Web-based and print resources to guide them through the process of online intervention development. Although useful for understanding many aspects of best practices for website development, missing from these resources are concrete examples of experiences in online intervention development for health apps from the perspective of those conducting online health interventions.
Objective
This study aims to serve as a series of case studies in the development of online health interventions to provide insights for researchers and practitioners who are considering technology-based interventional or programmatic approaches.
Methods
A convenience sample of six study coordinators and five principal investigators at a large, US-based land grant university were interviewed about the process of developing online interventions in the areas of alcohol policy, adolescent health, medication adherence, and human immunodeficiency virus prevention in transgender persons and in men who have sex with men. Participants were asked questions that broadly addressed each of the four phases of the User-Centered Design Process Map from the US Department of Health and Human Services' Research-Based Web Design & Usability Guidelines. Interviews were audio recorded and transcribed. Qualitative codes were developed using line-by-line open coding for all transcripts, and all transcripts were coded independently by at least 2 authors. Differences among coders were resolved with discussion.
Results
We identified the following seven themes: (1) hire a strong (or at least the right) research team, (2) take time to plan before beginning the design process, (3) recognize that vendors and researchers have differing values, objectives, and language, (4) develop a detailed contract, (5) document all decisions and development activities, (6) use a content management system, and (7) allow extra time for testing and debugging your intervention. Each of these areas is discussed in detail, with supporting quotations from principal investigators and study coordinators.
Conclusions
The values held by members of each participating organization involved in the development of the online intervention or program, as well as the objectives that are trying to be met with the website, must be considered. These defined values and objectives should prompt an open and explicit discussion about the scope of work, budget, and other needs from the perspectives of each organization. Because of the complexity of developing online interventions, researchers and practitioners should become familiar with the process and how it may differ from the development and implementation of in-person interventions or programs. To assist with this, the intervention team should consider expanding the team to include experts in computer science or learning technologies, as well as taking advantage of institutional resources that will be needed for successful completion of the project. Finally, we describe the tradeoff between funds available for online intervention or program development and the complexity of the project.
doi:10.2196/jmir.3770
PMCID: PMC4319079  PMID: 25650702
Internet; public health; intervention; development
12.  A self-evaluation tool for integrated care services: the Development Model for Integrated Care applied in practice 
Purpose
The purpose of the workshop is to show the applications of the Development Model for Integrated Care (DMIC) in practice. This relatively new and validated model, can be used by integrated care practices to evaluate their integrated care, to assess their phase of development and reveal improvement areas. In the workshop the results of the use of the model in three types of integrated care settings in the Netherlands will be presented. Participants are offered practical instruments based on the validated DMIC to use in their own setting and will be introduced to the webbased tool.
Context
To integrate care from multiple providers into a coherent and streamlined client-focused service, a large number of activities and agreements have to be implemented like streamlining information flows and adequate transfers of clients. In the large range of possible activities it is often not clear what essential activities are and where to start or continue. Also, knowledge about how to further develop integrated care services is needed. The Development Model for Integrated Care (DMIC), based on PhD research of Mirella Minkman, describes nine clusters containing in total 89 elements that contribute to the integration of care. The clusters are named: ‘client-centeredness’, ‘delivery system’, ‘performance management’, ‘quality of care’, ‘result-focused learning’, ‘interprofessional teamwork’, ‘roles and tasks’, ‘commitment’, and ‘transparant entrepreneurship’ [1–3]. In 2011 a new digital webbased self-evolution tool which contains the 89 elements grouped in nine clusters was developed. The DMIC also describes four phases of development [4]. The model is empirically validated in practice by assessing the relevance and implementation of the elements and development phases in 84 integrated care services in The Netherlands: in stroke, acute myocardial infarct (AMI), and dementia services. The validation studies are recently published [5, 6]. In 2011 also other integrated care services started using the model [7]. Vilans developed a digital web-based self-evaluation tool for integrated care services based on the DMIC. A palliative care network, four diabetes services, a youth care service and a network for autism used the self-evaluation tool to evaluate the development of their integrated care service. Because of its generic character, the model and tool are believed to be also interesting internationally.
Data sources
In the workshop we will present the results of three studies in integrated diabetes, youth and palliative care. The three projects consist of multiple steps, see below. Workshop participants could also work with the DMIC following these steps.
One: Preparation of the digital self-evolution tool for integrated care services
Although they are very different, the three integrated care services all wanted to gain insight in their development and improvement opportunities. We tailored the digital self-evaluation tool for each specific integrated care services, but for all the basis was the DMIC. Personal accounts for the digital DMIC self-evalution survey were sent to multiple partners working in each integrated care service (4–16 partners).
Two: Use of the online self-evaluation tool each partner of the local integrated care setting evaluated the integrated care by filling in the web-based questionnaire. The tool consists of three parts (A-C) named: general information about the integrated care practice (A); the clusters and elements of the DMIC (B); and the four phases of development (C). The respondents rated the relevance and presence of each element in their integrated care practice. Respondents were asked to estimate in which phase of development their thought their service was.
Three: Analysing the results
Advisers from Vilans, the Centre of excellence for long-term care in the Netherlands, analysed the self-evolution results in cooperation with the integrated care coordinators. The results show the total amount of implemented integrated care elements per cluster in spider graphs and the development phase as calculated by the DMIC model. Suggestions for further development of the integrated care services were analysed and reported.
Four: Discussing the implications for further development
In a workshop with the local integrated care partners the results of the self-evaluation were presented and discussed. We noticed remarkable results and highlight elements for further development. In addition, we gave advice for further development appropriate to the development phase of the integrated care service. Furthermore, the professionals prioritized the elements and decided which elements to start working on. This resulted in a (quality improvement) plan for the further development of the integrated care service.
Five: Reporting results
In a report all the results of the survey (including consensus scores) and the workshops came together. The integrated care coordinators stated that the reports really helped them to assess their improvement strategy. Also, there was insight in the development phase of their service which gave tools for further development.
Case description
The three cases presented are a palliative network, an integrated diabetes services and an integrated care network for youth in the Netherlands. The palliative care network wanted to reflect on their current development, to build a guiding framework for further development of the network. About sixteen professionals within the network worked with the digital self-evaluation tool and the DMIC: home care organisations, welfare organizations, hospice centres, health care organisations, community organizations.
For diabetes care, a Dutch health care insurance company wished to gain insight in the development of the contracted integrated care services to stimulate further development of the services. Professionals of three diabetes integrated care services were invited to fill in the digital self-evaluation tool. Of each integrated care service professionals like a general practitioner, a diabetes nurse, a medical specialist, a dietician and a podiatrist were invited. In youth care, a local health organisation wondered whether the DMIC could be helpful to visualize the results of youth integrated care services at process- and organisational level. The goal of the project was to define indicators at a process- and organisational level for youth care services based on the DMIC. In the future, these indicators might be used to evaluate youth care integrated care services and improve the quality of youth care within the Netherlands.
Conclusions and discussion
It is important for the quality of integrated care services that the involved coordinators, managers and professionals are aware of the development process of the integrated care service and that they focus on elements which can further develop and improve their integrated care. However, we noticed that integrated care services in the Netherlands experience difficulties in developing their integrated care service. It is often not clear what essential activities are to work on and how to further develop the integrated care service. A guiding framework for the development of integrated care was missing. The DMIC model has been developed for that reason and offers a useful tool for assessment, self-evaluation or improvement of integrated care services in practice. The model has been validated for AMI, dementia and stroke services. The latest new studies in diabetes, palliative care and youth care gave further insight in the generic character of the DMIC. Based on these studies it can be assumed that the DMIC can be used for multiple types of integrated care services. The model is assumed to be interesting for an international audience. Improving integrated care is a complex topic in a large number of countries; the DMIC is also based on the international literature. Dutch integrated care coordinators stated that the DMIC helped them to assess their integrated care development in practice and supported them in obtaining ideas for expanding and improving their integrated care activities.
The web-based self-evaluation tool focuses on a process- and organisational level of integrated care. Also, the self assessed development phase can be compared to the development phase as calculated by the DMIC tool. The cases showed this is fruitful input for discussions. When using the tool, the results can also be used in quality policy reports and improvement plans. The web-based tool is being tested at this moment in practice, but in San Marino we can present the latest webversion and demonstrate with a short video how to use the tool and model. During practical exercises in the workshop the participants will experience how the application of the DMIC can work for them in practice or in research. For integrated care researchers and policy makers, the DMIC questionnaire and tool is a promising method for further research and policy plans in integrated care.
PMCID: PMC3617779
development model for integrated care; development of integrated care services; implementation and improvement of integrated care; self evaluation
13.  Integration of a Mobile-Integrated Therapy with Electronic Health Records: Lessons Learned 
Background:
Responses to the chronic disease epidemic have predominantly been standardized in their approach to date. Barriers to better health outcomes remain, and effective management requires patient-specific data and disease state knowledge be presented in methods that foster clinical decision-making and patient self-management.
Mobile technology provides a new platform for data collection and patient–provider communication. The mobile device represents a personalized platform that is available to the patient on a 24/7 basis. Mobile-integrated therapy (MIT) is the convergence of mobile technology, clinical and behavioral science, and scientifically validated clinical outcomes. In this article, we highlight the lessons learned from functional integration of a Food and Drug Administration-cleared type 2 diabetes MIT into the electronic health record (EHR) of a multiphysician practice within a large, urban, academic medical center.
Methods:
In-depth interviews were conducted with integration stakeholder groups: mobile and EHR software and information technology teams, clinical end users, project managers, and business analysts. Interviews were summarized and categorized into lessons learned using the Architecture for Integrated Mobility® framework.
Results:
Findings from the diverse stakeholder group of a MIT–EHR integration project indicate that user workflow, software system persistence, environment configuration, device connectivity and security, organizational processes, and data exchange heuristics are key issues that must be addressed.
Conclusions:
Mobile-integrated therapy that integrates patient self-management data with medical record data provides the opportunity to understand the potential benefits of bidirectional data sharing and reporting that are most valuable in advancing better health and better care in a cost-effective way that is scalable for all chronic diseases.
PMCID: PMC3869127  PMID: 23759392
architecture-integrated mobility; clinical decision support; electronic health record; electronic medical record; meaningful use; mobile health; mHealth; mobile-integrated therapy; mobile medical device; self-management; self-management support; type 2 diabetes
14.  Introducing peer worker roles into UK mental health service teams: a qualitative analysis of the organisational benefits and challenges 
Background
The provision of peer support as a component of mental health care, including the employment of Peer Workers (consumer-providers) by mental health service organisations, is increasingly common internationally. Peer support is strongly advocated as a strategy in a number of UK health and social care policies. Approaches to employing Peer Workers are proliferating. There is evidence to suggest that Peer Worker-based interventions reduce psychiatric inpatient admission and increase service user (consumer) empowerment. In this paper we seek to address a gap in the empirical literature in understanding the organisational challenges and benefits of introducing Peer Worker roles into mental health service teams.
Methods
We report the secondary analysis of qualitative interview data from service users, Peer Workers, non-peer staff and managers of three innovative interventions in a study about mental health self-care. Relevant data was extracted from interviews with 41 participants and subjected to analysis using Grounded Theory techniques. Organisational research literature on role adoption framed the analysis.
Results
Peer Workers were highly valued by mental health teams and service users. Non-peer team members and managers worked hard to introduce Peer Workers into teams. Our cases were projects in development and there was learning from the evolutionary process: in the absence of formal recruitment processes for Peer Workers, differences in expectations of the Peer Worker role can emerge at the selection stage; flexible working arrangements for Peer Workers can have the unintended effect of perpetuating hierarchies within teams; the maintenance of protective practice boundaries through supervision and training can militate against the emergence of a distinctive body of peer practice; lack of consensus around what constitutes peer practice can result in feelings for Peer Workers of inequality, disempowerment, uncertainty about identity and of being under-supported.
Conclusions
This research is indicative of potential benefits for mental health service teams of introducing Peer Worker roles. Analysis also suggests that if the emergence of a distinctive body of peer practice is not adequately considered and supported, as integral to the development of new Peer Worker roles, there is a risk that the potential impact of any emerging role will be constrained and diluted.
doi:10.1186/1472-6963-13-188
PMCID: PMC3673834  PMID: 23705767
Mental health; Peer support; Secondary data analysis (qualitative); Health services research; Recovery; Consumer participation; Service user involvement; Community psychiatry; Role adoption; Workforce development
15.  A model for scale up of family health innovations in low-income and middle-income settings: a mixed methods study 
BMJ Open  2012;2(4):e000987.
Background
Many family health innovations that have been shown to be both efficacious and cost-effective fail to scale up for widespread use particularly in low-income and middle-income countries (LMIC). Although individual cases of successful scale-up, in which widespread take up occurs, have been described, we lack an integrated and practical model of scale-up that may be applicable to a wide range of public health innovations in LMIC.
Objective
To develop an integrated and practical model of scale-up that synthesises experiences of family health programmes in LMICs.
Data sources
We conducted a mixed methods study that included in-depth interviews with 33 key informants and a systematic review of peer-reviewed and grey literature from 11 electronic databases and 20 global health agency web sites.
Study eligibility criteria, participants and interventions
We included key informants and studies that reported on the scale up of several family health innovations including Depo-Provera as an example of a product innovation, exclusive breastfeeding as an example of a health behaviour innovation, community health workers (CHWs) as an example of an organisational innovation and social marketing as an example of a business model innovation. Key informants were drawn from non-governmental, government and international organisations using snowball sampling. An article was excluded if the article: did not meet the study's definition of the innovation; did not address dissemination, diffusion, scale up or sustainability of the innovation; did not address low-income or middle-income countries; was superficial in its discussion and/or did not provide empirical evidence about scale-up of the innovation; was not available online in full text; or was not available in English, French, Spanish or Portuguese, resulting in a final sample of 41 peer-reviewed articles and 30 grey literature sources.
Study appraisal and synthesis methods
We used the constant comparative method of qualitative data analysis to extract recurrent themes from the interviews, and we integrated these themes with findings from the literature review to generate the proposed model of scale-up. For the systematic review, screening was conducted independently by two team members to ensure consistent application of the predetermined exclusion criteria. Data extraction from the final sample of peer-reviewed and grey literature was conducted independently by two team members using a pre-established data extraction form to list the enabling factors and barriers to dissemination, diffusion, scale up and sustainability.
Results
The resulting model—the AIDED model—includes five non-linear, interrelated components: (1) assess the landscape, (2) innovate to fit user receptivity, (3) develop support, (4) engage user groups and (5) devolve efforts for spreading innovation. Our findings suggest that successful scale-up occurs within a complex adaptive system, characterised by interdependent parts, multiple feedback loops and several potential paths to achieve intended outcomes. Failure to scale up may be attributable to insufficient assessment of user groups in context, lack of fit of the innovation with user receptivity, inability to address resistance from stakeholders and inadequate engagement with user groups.
Limitations
The inductive approach used to construct the AIDED model did not allow for simultaneous empirical testing of the model. Furthermore, the literature may have publication bias in which negative studies are under-represented, although we did find examples of unsuccessful scale-up. Last, the AIDED model did not address long-term, sustained use of innovations that are successfully scaled up, which would require longer-term follow-up than is common in the literature.
Conclusions and implications of key findings
Flexible strategies of assessment, innovation, development, engagement and devolution are required to enable effective change in the use of family health innovations in LMIC.
doi:10.1136/bmjopen-2012-000987
PMCID: PMC3432850  PMID: 22923624
Health Services Administration & Management; Health policy; International health services; Public Health; Scale up
16.  Uptake of evidence in policy development: the case of user fees for health care in public health facilities in Uganda 
Background
Several countries in Sub Saharan Africa have abolished user fees for health care but the extent to which such a policy decision is guided by evidence needs further exploration. We explored the barriers and facilitating factors to uptake of evidence in the process of user fee abolition in Uganda and how the context and stakeholders involved shaped the uptake of evidence. This study builds on previous work in Uganda that led to the development of a middle range theory (MRT) outlining the main facilitating factors for knowledge translation (KT). Application of the MRT to the case of abolition of user fees contributes to its refining.
Methods
Employing a theory-driven inquiry and case study approach given the need for in-depth investigation, we reviewed documents and conducted interviews with 32 purposefully selected key informants. We assessed whether evidence was available, had or had not been considered in policy development and the reasons why and; assessed how the actors and the context shaped the uptake of evidence.
Results
Symbolic, conceptual and instrumental uses of evidence were manifest. Different actors were influenced by different types of evidence. While technocrats in the ministry of health (MoH) relied on formal research, politicians relied on community complaints. The capacity of the MoH to lead the KT process was weak and the partnerships for KT were informal. The political window and alignment of the evidence with overall government discourse enhanced uptake of evidence. Stakeholders were divided, seemed to be polarized for various reasons and had varying levels of support and influence impacting the uptake of evidence.
Conclusion
Evidence will be taken up in policy development in instances where the MoH leads the KT process, there are partnerships for KT in place, and the overall government policy and the political situation can be expected to play a role. Different actors will be influenced by different types of evidence and their level of support and influence will impact the uptake of evidence. In addition, the extent to which a policy issue is contested and, whether stakeholders share similar opinions and preferences will impact the uptake of evidence.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-014-0639-5) contains supplementary material, which is available to authorized users.
doi:10.1186/s12913-014-0639-5
PMCID: PMC4310169  PMID: 25560092
User fees; Health care; Public facilities; Policy development; Knowledge translation; Uganda
17.  User Preferences and Design Recommendations for an mHealth App to Promote Cystic Fibrosis Self-Management 
JMIR mHealth and uHealth  2014;2(4):e44.
Background
mHealth apps hold potential to provide automated, tailored support for treatment adherence among individuals with chronic medical conditions. Yet relatively little empirical research has guided app development and end users are infrequently involved in designing the app features or functions that would best suit their needs. Self-management apps may be particularly useful for people with chronic conditions like cystic fibrosis (CF) that have complex, demanding regimens.
Objective
The aim of this mixed-methods study was to involve individuals with CF in guiding the development of engaging, effective, user-friendly adherence promotion apps that meet their preferences and self-management needs.
Methods
Adults with CF (n=16, aged 21-48 years, 50% male) provided quantitative data via a secure Web survey and qualitative data via semi-structured telephone interviews regarding previous experiences using apps in general and for health, and preferred and unwanted features of potential future apps to support CF self-management.
Results
Participants were smartphone users who reported sending or receiving text messages (93%, 14/15) or emails (80%, 12/15) on their smartphone or device every day, and 87% (13/15) said it would be somewhat or very hard to give up their smartphone. Approximately one-half (53%, 8/15) reported having health apps, all diet/weight-related, yet many reported that existing nutrition apps were not well-suited for CF management. Participants wanted apps to support CF self-management with characteristics such as having multiple rather than single functions (eg, simple alarms), being specific to CF, and minimizing user burden. Common themes for desired CF app features were having information at one’s fingertips, automation of disease management activities such as pharmacy refills, integration with smartphones’ technological capabilities, enhancing communication with health care team, and facilitating socialization within the CF community. Opinions were mixed regarding gamification and earning rewards or prizes. Participants emphasized the need for customization options to meet individual preferences and disease management goals.
Conclusions
Unique capabilities of emerging smartphone technologies (eg, social networking integration, movement and location detection, integrated sensors, or electronic monitors) make many of these requests possible. Involving end users in all stages of mHealth app development and collaborating with technology experts and the health care system may result in apps that maintain engagement, improve integration and automation, and ultimately impact self-management and health outcomes.
doi:10.2196/mhealth.3599
PMCID: PMC4259916  PMID: 25344616
cystic fibrosis; qualitative research; mobile health
18.  Factors Influencing the Use of a Web-Based Application for Supporting the Self-Care of Patients with Type 2 Diabetes: A Longitudinal Study 
Background
The take-up of eHealth applications in general is still rather low and user attrition is often high. Only limited information is available about the use of eHealth technologies among specific patient groups.
Objective
The aim of this study was to explore the factors that influence the initial and long-term use of a Web-based application (DiabetesCoach) for supporting the self-care of patients with type 2 diabetes.
Methods
A mixed-methods research design was used for a process analysis of the actual usage of the Web application over a 2-year period and to identify user profiles. Research instruments included log files, interviews, usability tests, and a survey.
Results
The DiabetesCoach was predominantly used for interactive features like online monitoring, personal data, and patient–nurse email contact. It was the continuous, personal feedback that particularly appealed to the patients; they felt more closely monitored by their nurse and encouraged to play a more active role in self-managing their disease. Despite the positive outcomes, usage of the Web application was hindered by low enrollment and nonusage attrition. The main barrier to enrollment had to do with a lack of access to the Internet (146/226, 65%). Although 68% (34/50) of the enrollees were continuous users, of whom 32% (16/50) could be defined as hardcore users (highly active), the remaining 32% (16/50) did not continue using the Web application for the full duration of the study period. Barriers to long-term use were primarily due to poor user-friendliness of the Web application (the absence of “push” factors or reminders) and selection of the “wrong” users; the well-regulated patients were not the ones who could benefit the most from system use because of a ceiling effect. Patients with a greater need for care seemed to be more engaged in long-term use; highly active users were significantly more often medication users than low/inactive users (P = .005) and had a longer diabetes duration (P = .03).
Conclusion
Innovations in health care will diffuse more rapidly when technology is employed that is simple to use and has applicable components for interactivity. This would foresee the patients’ need for continuous and personalized feedback, in particular for patients with a greater need for care. From this study several factors appear to influence increased use of eHealth technologies: (1) avoiding selective enrollment, (2) making use of participatory design methods, and (3) developing push factors for persistence. Further research should focus on the causal relationship between using the system’s features and actual usage, as such a view would provide important evidence on how specific technology features can engage and captivate users.
doi:10.2196/jmir.1603
PMCID: PMC3222177  PMID: 21959968
Internet; technology; eHealth; email; communication; primary care; self-care; diabetes
19.  SOMWeb: A Semantic Web-Based System for Supporting Collaboration of Distributed Medical Communities of Practice 
Background
Information technology (IT) support for remote collaboration of geographically distributed communities of practice (CoP) in health care must deal with a number of sociotechnical aspects of communication within the community. In the mid-1990s, participants of the Swedish Oral Medicine Network (SOMNet) began discussing patient cases in telephone conferences. The cases were distributed prior to the conferences using PowerPoint and email. For the technical support of online CoP, Semantic Web technologies can potentially fulfill needs of knowledge reuse, data exchange, and reasoning based on ontologies. However, more research is needed on the use of Semantic Web technologies in practice.
Objectives
The objectives of this research were to (1) study the communication of distributed health care professionals in oral medicine; (2) apply Semantic Web technologies to describe community data and oral medicine knowledge; (3) develop an online CoP, Swedish Oral Medicine Web (SOMWeb), centered on user-contributed case descriptions and meetings; and (4) evaluate SOMWeb and study how work practices change with IT support.
Methods
Based on Java, and using the Web Ontology Language and Resource Description Framework for handling community data and oral medicine knowledge, SOMWeb was developed using a user-centered and iterative approach. For studying the work practices and evaluating the system, a mixed-method approach of interviews, observations, and a questionnaire was used.
Results
By May 2008, there were 90 registered users of SOMWeb, 93 cases had been added, and 18 meetings had utilized the system. The introduction of SOMWeb has improved the structure of meetings and their discussions, and a tenfold increase in the number of participants has been observed. Users submit cases to seek advice on diagnosis or treatment, to show an unusual case, or to create discussion. Identified barriers to submitting cases are lack of time, concern about whether the case is interesting enough, and showing gaps in one’s own knowledge. Three levels of member participation are discernable: a core group that contributes most cases and most meeting feedback; an active group that participates often but only sometimes contribute cases and feedback; and a large peripheral group that seldom or never contribute cases or feedback.
Conclusions
SOMWeb is beneficial for individual clinicians as well as for the SOMNet community. The system provides an opportunity for its members to share both high quality clinical practice knowledge and external evidence related to complex oral medicine cases. The foundation in Semantic Web technologies enables formalization and structuring of case data that can be used for further reasoning and research. Main success factors are the long history of collaboration between different disciplines, the user-centered development approach, the existence of a “champion” within the field, and nontechnical community aspects already being in place.
doi:10.2196/jmir.1059
PMCID: PMC2626431  PMID: 18725355
Dental informatics; medical informatics applications; communications applications; community networks; group and organization interfaces; interdisciplinary communication; Internet; knowledge bases; online information services; user/machine systems
20.  User-centred development of a monitoring and feedback tool to stimulate physical activity 
Introduction
Although physical activity has many positive effects on the quality of life and prognosis, it is very difficult for people with COPD or diabetes type 2 (DM2) to be sufficiently active. Unfortunately, the long-term adherence to several care interventions that try to enhance the physical activity level of these people is generally low. Self-monitoring and feedback integrated in technology might help promoting and sustaining an active lifestyle, especially when it is part of health care services. As a prerequisite, for useful technology and a successful intervention that meets the requirements and preferences of the end users, it is important to involve the end users in the design process at an early stage.
Aim
In this contribution we report how users were involved in the design of an innovative monitoring and feedback tool to support self-management of an active lifestyle for COPD and DM2 patients. This tool will be implemented in primary care in a Self-management Support Program (SSP). Users were involved in particular to elicit:
Which feedback they need to optimally support them in their self-management.
How this feedback should be presented.
How the tool could be designed in order to be attractive, easy to use and suitable to wear on a daily basis.
Methods
An iterative user-centred approach was used to design both the tool and the SSP. Patients, care professionals and technicians were actively involved in the development process. Two patient representatives were added to the research team to help outlining the research strategy. A multidisciplinary team of technicians and computer engineers was established to help deciding on the development of the tool. Sixteen care professionals, 7 COPD and 8 DM2 patients were involved in interviews and focus groups to elicit the functional requirements of the tool.
Results
The conceptual idea of the tool is adapted to the requirements and preferences of the end users. The user-centred design process resulted in a self-management tool that consists of three parts: an accelerometer that monitors physical activity, a smartphone that shows feedback based on this activity and tailored to personal goals, and a server that stores the data and sends the feedback messages to the patients. This server also provides a summary to practice nurses, to prepare them for consultations, telephone calls or email conversations with patients.
Conclusions
The involvement of end users in the development of the tool has led to new insights that increase its acceptability and usability. The tool will soon be validated and tested in pilot studies. The effects of the Self-management Support Program with the tool, embedded in primary care, will be measured in an RCT.
PMCID: PMC3571178
self management; physical activity; persuasive technology; primary care
21.  Comparative Case Study of Two Biomedical Research Collaboratories 
Background
Working together efficiently and effectively presents a significant challenge in large-scale, complex, interdisciplinary research projects. Collaboratories are a nascent method to help meet this challenge. However, formal collaboratories in biomedical research centers are the exception rather than the rule.
Objective
The main purpose of this paper is to compare and describe two collaboratories that used off-the-shelf tools and relatively modest resources to support the scientific activity of two biomedical research centers. The two centers were the Great Lakes Regional Center for AIDS Research (HIV/AIDS Center) and the New York University Oral Cancer Research for Adolescent and Adult Health Promotion Center (Oral Cancer Center).
Methods
In each collaboratory, we used semistructured interviews, surveys, and contextual inquiry to assess user needs and define the technology requirements. We evaluated and selected commercial software applications by comparing their feature sets with requirements and then pilot-testing the applications. Local and remote support staff cooperated in the implementation and end user training for the collaborative tools. Collaboratory staff evaluated each implementation by analyzing utilization data, administering user surveys, and functioning as participant observers.
Results
The HIV/AIDS Center primarily required real-time interaction for developing projects and attracting new participants to the center; the Oral Cancer Center, on the other hand, mainly needed tools to support distributed and asynchronous work in small research groups. The HIV/AIDS Center’s collaboratory included a center-wide website that also served as the launch point for collaboratory applications, such as NetMeeting, Timbuktu Conference, PlaceWare Auditorium, and iVisit. The collaboratory of the Oral Cancer Center used Groove and Genesys Web conferencing. The HIV/AIDS Center was successful in attracting new scientists to HIV/AIDS research, and members used the collaboratory for developing and implementing new research studies. The Oral Cancer Center successfully supported highly distributed and asynchronous research, and the collaboratory facilitated real-time interaction for analyzing data and preparing publications.
Conclusions
The two collaboratory implementations demonstrated the feasibility of supporting biomedical research centers using off-the-shelf commercial tools, but they also identified several barriers to successful collaboration. These barriers included computing platform incompatibilities, network infrastructure complexity, variable availability of local versus remote IT support, low computer and collaborative software literacy, and insufficient maturity of available collaborative software. Factors enabling collaboratory use included collaboration incentives through funding mechanism, a collaborative versus competitive relationship of researchers, leadership by example, and tools well matched to tasks and technical progress. Integrating electronic collaborative tools into routine scientific practice can be successful but requires further research on the technical, social, and behavioral factors influencing the adoption and use of collaboratories.
doi:10.2196/jmir.7.5.e53
PMCID: PMC1408071  PMID: 16403717
Biomedical research; collaboration; collaboratories; community networks; information technology; interdisciplinary research
22.  Health and Human Rights Concerns of Drug Users in Detention in Guangxi Province, China 
PLoS Medicine  2008;5(12):e234.
Background
Although confinement in drug detoxification (“detox”) and re-education through labor (RTL) centers is the most common form of treatment for drug dependence in China, little has been published about the experience of drug users in such settings. We conducted an assessment of the impact of detention on drug users' access to HIV prevention and treatment services and consequent threats to fundamental human rights protections.
Methods and Findings
Chinese government HIV and anti-narcotics legislation and policy documents were reviewed, and in-depth and key informant interviews were conducted with 19 injection drug users (IDUs) and 20 government and nongovernmental organization officials in Nanning and Baise, Guangxi Province. Significant contradictions were found in HIV and antinarcotics policies, exemplified by the simultaneous expansion of community-based methadone maintenance therapy and the increasing number of drug users detained in detox and RTL center facilities. IDU study participants reported, on average, having used drugs for 14 y (range 8–23 y) and had been confined to detox four times (range one to eight times) and to RTL centers once (range zero to three times). IDUs expressed an intense fear of being recognized by the police and being detained, regardless of current drug use. Key informants and IDUs reported that routine HIV testing, without consent and without disclosure of the result, was the standard policy of detox and RTL center facilities, and that HIV-infected detainees were not routinely provided medical or drug dependency treatment, including antiretroviral therapy. IDUs received little or no information or means of HIV prevention, but reported numerous risk behaviors for HIV transmission while detained.
Conclusions
Legal and policy review, and interviews with recently detained IDUs and key informants in Guangxi Province, China, found evidence of anti-narcotics policies and practices that appear to violate human rights and imperil drug users' health.
Based on their review of Chinese government legislation and policy documents, and using interviews with recently detained injection drug users and officials in Guangxi Province, Elizabeth Cohen and Joseph Amon find evidence of antinarcotics policies and practices that may compromise the health and human rights of drug users.
Editors' Summary
Background.
Ever since the AIDS (acquired immunodeficiency syndrome) epidemic began, needle sharing by injection drug users (IDUs) has been a major transmission route for the human immunodeficiency virus (HIV), the blood-borne virus that causes AIDS. In China, for example, the AIDS epidemic began in earnest in 1989 when 146 HIV-positive IDUs were identified in Southwest Yunnan. By 1998, HIV infections had been reported throughout China, 60%–70% of which were in IDUs. These days, nearly half of new HIV infections in China are associated with injection drug use and 266,000 of the 700,000 HIV-positive people in China are drug users. Faced with these figures, the Chinese government has recently introduced measures to reduce HIV transmission among the estimated 3–4 million IDUs in China. These measures include increased provision of methadone maintenance treatment clinics and needle exchanges and the establishment of HIV prevention programs that target IDUs.
Why Was This Study Done?
Alongside these progressive public-health practices, China has extremely punitive anti-narcotics policies. IDUs are routinely confined without legal review in drug detoxification centers or sent to re-education through labor (RTL) centers, sometimes for many years. In 2005, these centers housed more than 350,000 drug users yet little is known about the conditions in these centers or how the Chinese anti-narcotic policy affects human rights or access to HIV prevention and treatment services. In this study, the researchers investigated these issues by interviewing IDUs and “key informants” (government officials and members of nongovernmental organizations [NGOs] who provide services to IDUs) about their experiences of detoxification centers and RTL centers in two cities in Guangxi Province, China.
What Did the Researchers Do and Find?
The researchers recruited 19 IDUs who had been recently confined in a detoxification center or RTL center and 20 key informants (including a doctor at a detoxification center and a former RTL center guard). In the interviews the researchers used a semi-structured questionnaire to ask the participants about their experiences of detoxification centers and RTL centers. All the IDUs reported that they were repeatedly tested for HIV while in detention but never given their test results even when they asked for them. Key informants confirmed that repeated HIV testing without result disclosure is the current policy in detoxification centers and RTL centers. All the IDUs expressed concerns about inadequate access to health care in detention. In particular, most of the IDUs who were taking antiretroviral drugs before detention were unable to continue their treatment during detention, although two received antiretroviral drugs by negotiating with their guards. The IDUs and key informants also both noted that very little information or means of HIV prevention was provided in the detoxification centers and RTL centers and that HIV-related risk behaviors, including injection drug use and unsafe sex, occurred in both types of center. Finally, the IDUs reported that their fear of being recognized by the police and detained even if not taking drugs prevented them from seeking HIV tests, HIV treatment, and help for their drug addiction.
What Do These Findings Mean?
This study has several limitations in addition to its small size. For example, because the IDUs were self selected—they responded to posters asking if they would be interviewed—their views may not be representative of all IDUs. Similarly, the key informants who were interviewed might have had different opinions from those who chose not to participate. Furthermore, the results reported here cannot be generalized to other areas of China. Nevertheless, the consistent experiences reported by the IDUs and confirmed by the key informants suggest that China's anti-narcotic policies and practices violate the human rights of IDUs and put their health in danger by making it hard for them to access HIV prevention and treatment or adequate treatment for their drug addiction. This situation, if not remedied, is likely to jeopardize China's attempts to control its HIV epidemic.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050234.
This study is further discussed in a PLoS Medicine Perspective by Steve Koester
Avert, an international AIDS charity, provides information on all aspects of HIV/AIDS, including HIV and AIDS in China and HIV prevention, harm reduction, and injecting drug use
The UNAIDS 2008 Country Progress Report provides up-to-date details about the AIDS situation in China
HIVInSite provides links to more information about HIV/AIDS in China.
Human Rights Watch works on health and human rights and human rights developments in China
The US National Institute on Drug Abuse provides a booklet entitled Principles of Drug Addiction Treatment: A Research Based Guide (in English and Spanish)
UN Office on Drugs and Crime has information on HIV/AIDS in prisons
doi:10.1371/journal.pmed.0050234
PMCID: PMC2596857  PMID: 19071954
23.  Innovating alongside designers 
Building alliances with industrial designers offers health innovators a unique pathway to create new modes to serve their patients. Cross-pollination of ideas from the earliest stages of development in interdisciplinary research and development teams including major stakeholders and designers can lead to more meaningful and impactful innovations.
A shift in future healthcare from cure to prevention will rely more heavily upon the individual. The home environment will house consumer medical devices that will carry out basic monitoring of the individual. While technologies are currently being developed to support this trend, there is a gulf that exists between the often-complex interfaces required by the highly specific functionality of products and the emotional needs of the target user. If a target user ‘feels’ a product was designed ‘just for them’ they are more likely to develop an emotional bond with that product. This manifests itself in the user engaging and interacting with the product. If a product, regardless of its high functionality, does not resonate with the user, this tends to result in product underuse, misuse and possible abandonment. When those products are related to a course of medical rehabilitation or treatment, these results could be translated to ‘more compliant’ and ‘less compliant’ and ultimately can impact upon how a person heals.
Industrial designers focus on ensuring that both the functional and emotional needs of mainstream users as well as technical-expert-users are met. Design research provides the opportunity to bridge the gap between the functional requirements and the less tangible unmet needs of the user by exploring authentic human behaviour.
This paper presents case studies of collaborative, interdisciplinary teams employing human-centred design and empathic research strategies (incorporating shared language, collaboration, ethnography, empathy and empathic modelling) to create real solutions that are responding to real needs of real users.
The future is interdisciplinary. The future is bright.
doi:10.4066/AMJ.2013.1586
PMCID: PMC3575064  PMID: 23424180
Human-centred design; research strategies; emotional needs; authentic human behaviour
24.  Using participatory design to develop (public) health decision support systems through GIS 
Background
Organizations that collect substantial data for decision-making purposes are often characterized as being 'data rich' but 'information poor'. Maps and mapping tools can be very useful for research transfer in converting locally collected data into information. Challenges involved in incorporating GIS applications into the decision-making process within the non-profit (public) health sector include a lack of financial resources for software acquisition and training for non-specialists to use such tools. This on-going project has two primary phases. This paper critically reflects on Phase 1: the participatory design (PD) process of developing a collaborative web-based GIS tool.
Methods
A case study design is being used whereby the case is defined as the data analyst and manager dyad (a two person team) in selected Ontario Early Year Centres (OEYCs). Multiple cases are used to support the reliability of findings. With nine producer/user pair participants, the goal in Phase 1 was to identify barriers to map production, and through the participatory design process, develop a web-based GIS tool suited for data analysts and their managers. This study has been guided by the Ottawa Model of Research Use (OMRU) conceptual framework.
Results
Due to wide variations in OEYC structures, only some data analysts used mapping software and there was no consistency or standardization in the software being used. Consequently, very little sharing of maps and data occurred among data analysts. Using PD, this project developed a web-based mapping tool (EYEMAP) that was easy to use, protected proprietary data, and permit limited and controlled sharing between participants. By providing data analysts with training on its use, the project also ensured that data analysts would not break cartographic conventions (e.g. using a chloropleth map for count data). Interoperability was built into the web-based solution; that is, EYEMAP can read many different standard mapping file formats (e.g. ESRI, MapInfo, CSV).
Discussion
Based on the evaluation of Phase 1, the PD process has served both as a facilitator and a barrier. In terms of successes, the PD process identified two key components that are important to users: increased data/map sharing functionality and interoperability. Some of the challenges affected developers and users; both individually and as a collective. From a development perspective, this project experienced difficulties in obtaining personnel skilled in web application development and GIS. For users, some data sharing barriers are beyond what a technological tool can address (e.g. third party data). Lastly, the PD process occurs in real time; both a strength and a limitation. Programmatic changes at the provincial level and staff turnover at the organizational level made it difficult to maintain buy-in as participants changed over time. The impacts of these successes and challenges will be evaluated more concretely at the end of Phase 2.
Conclusion
PD approaches, by their very nature, encourage buy-in to the development process, better addresses user-needs, and creates a sense of user-investment and ownership.
doi:10.1186/1476-072X-6-53
PMCID: PMC2175500  PMID: 18042298
25.  Mobile and Fixed Computer Use by Doctors and Nurses on Hospital Wards: Multi-method Study on the Relationships Between Clinician Role, Clinical Task, and Device Choice 
Background
Selecting the right mix of stationary and mobile computing devices is a significant challenge for system planners and implementers. There is very limited research evidence upon which to base such decisions.
Objective
We aimed to investigate the relationships between clinician role, clinical task, and selection of a computer hardware device in hospital wards.
Methods
Twenty-seven nurses and eight doctors were observed for a total of 80 hours as they used a range of computing devices to access a computerized provider order entry system on two wards at a major Sydney teaching hospital. Observers used a checklist to record the clinical tasks completed, devices used, and location of the activities. Field notes were also documented during observations. Semi-structured interviews were conducted after observation sessions. Assessment of the physical attributes of three devices—stationary PCs, computers on wheels (COWs) and tablet PCs—was made. Two types of COWs were available on the wards: generic COWs (laptops mounted on trolleys) and ergonomic COWs (an integrated computer and cart device). Heuristic evaluation of the user interfaces was also carried out.
Results
The majority (93.1%) of observed nursing tasks were conducted using generic COWs. Most nursing tasks were performed in patients’ rooms (57%) or in the corridors (36%), with a small percentage at a patient’s bedside (5%). Most nursing tasks related to the preparation and administration of drugs. Doctors on ward rounds conducted 57.3% of observed clinical tasks on generic COWs and 35.9% on tablet PCs. On rounds, 56% of doctors’ tasks were performed in the corridors, 29% in patients’ rooms, and 3% at the bedside. Doctors not on a ward round conducted 93.6% of tasks using stationary PCs, most often within the doctors’ office. Nurses and doctors were observed performing workarounds, such as transcribing medication orders from the computer to paper.
Conclusions
The choice of device was related to clinical role, nature of the clinical task, degree of mobility required, including where task completion occurs, and device design. Nurses’ work, and clinical tasks performed by doctors during ward rounds, require highly mobile computer devices. Nurses and doctors on ward rounds showed a strong preference for generic COWs over all other devices. Tablet PCs were selected by doctors for only a small proportion of clinical tasks. Even when using mobile devices clinicians completed a very low proportion of observed tasks at the bedside. The design of the devices and ward space configurations place limitations on how and where devices are used and on the mobility of clinical work. In such circumstances, clinicians will initiate workarounds to compensate. In selecting hardware devices, consideration should be given to who will be using the devices, the nature of their work, and the physical layout of the ward.
doi:10.2196/jmir.1221
PMCID: PMC2762853  PMID: 19674959
Study; multi-method study; observational study; mobility; mobile computers; computers; computer hardware; medical order entry systems; computerized physician order entry system; computerized provider order entry (CPOE)

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