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1.  Internet Cancer Support Groups 
Cancer nursing  2005;28(1):1-7.
Internet Cancer Support Groups (ICSGs) are an emerging form of support group on Internet specifically for cancer patients. Previous studies have indicated the effectiveness of ICSGs as a research setting or a data-collection method. Yet recent studies have also indicated that ICSGs tend to serve highly educated, high-income White males who tend to be at an early stage of cancer. In this article, a total of 317 general ICSGs and 229 ethnic-specific ICSGs searched through Google.com, Yahoo.com, http://Msn.com, AOL.com, and ACOR.org are analyzed from a feminist perspective. The written records of group discussions and written memos by the research staff members were also analyzed using content analysis. The idea categories that emerged about these groups include (a) authenticity issues; (b) ethnicity and gender issues; (c) intersubjectivity issues; and (d) potential ethical issues. The findings suggest that (a) researchers adopt multiple recruitment strategies through various Internet sites and/or real settings; (b) researchers raise their own awareness of the potential influences of the health-related resources provided by ICSGs and regularly update their knowledge related to the federal and state standards and/or policies related to ICSGs; and (c) researchers consider adopting a quota-sampling method.
PMCID: PMC1409749  PMID: 15681976
Analysis; Cancer; Feminist; Internet; Support groups
2.  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
3.  An Online Forum As a Qualitative Research Method: Practical Issues 
Nursing research  2006;55(4):267-273.
Background
Despite positive aspects of online forums as a qualitative research method, very little is known about practical issues involved in using online forums for data collection, especially for a qualitative research project.
Objectives
The purpose of this paper is to describe the practical issues that the researchers encountered in implementing an online forum as a qualitative component of a larger study on cancer pain experience.
Method
Throughout the study process, the research staff recorded issues ranged from minor technical problems to serious ethical dilemmas as they arose and wrote memos about them. The memos and written records of discussions were reviewed and analyzed using the content analysis suggested by Weber.
Results
Two practical issues related to credibility were identified: a high response and retention rate and automatic transcripts. An issue related to dependability was the participants’ easy forgetfulness. The issues related to confirmability were difficulties in theoretical saturation and unstandardized computer and Internet jargon. A security issue related to hacking attempts was noted as well.
Discussion
The analysis of these issues suggests several implications for future researchers who want to use online forums as a qualitative data collection method.
PMCID: PMC2491331  PMID: 16849979
Issues; Online Forums; Cancer Patients; Qualitative Research
4.  Internet trials: participant experiences and perspectives 
Background
Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial.
Objective
To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research.
Methods
All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey.
Results
1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69%) would prefer to participate in Internet-based research compared to other modes of data collection in the future.
Conclusion
Participants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants’ perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience – a perceived benefit – and lack of connectedness and understanding – a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials.
doi:10.1186/1471-2288-12-162
PMCID: PMC3533967  PMID: 23092116
Internet; Randomized controlled trials; Participant experience; Methods; Methodology
5.  Internet Use among Ugandan Adolescents: Implications for HIV Intervention 
PLoS Medicine  2006;3(11):e433.
Background
The Internet is fast gaining recognition as a powerful, low-cost method to deliver health intervention and prevention programs to large numbers of young people across diverse geographic regions. The feasibility and accessibility of Internet-based health interventions in resource-limited settings, where cost-effective interventions are most needed, is unknown. To determine the utility of developing technology-based interventions in resource-limited settings, availability and patterns of usage of the Internet first need to be assessed.
Methods and Findings
The Uganda Media and You Survey was a cross-sectional survey of Internet use among adolescents (ages 12–18 years) in Mbarara, Uganda, a municipality mainly serving a rural population in sub-Saharan Africa. Participants were randomly selected among eligible students attending one of five participating secondary day and boarding schools in Mbarara, Uganda. Of a total of 538 students selected, 93% (500) participated.
Of the total respondents, 45% (223) reported ever having used the Internet, 78% (175) of whom reported going online in the previous week. As maternal education increased, so too did the odds of adolescent Internet use. Almost two in five respondents (38% [189]) reported already having used a computer or the Internet to search for health information. Over one-third (35% [173]) had used the computer or Internet to find information about HIV/AIDS, and 20% (102) had looked for sexual health information. Among Internet users, searching for HIV/AIDS information on a computer or online was significantly related to using the Internet weekly, emailing, visiting chat rooms, and playing online games. In contrast, going online at school was inversely related to looking for HIV/AIDS information via technology. If Internet access were free, 66% (330) reported that they would search for information about HIV/AIDS prevention online.
Conclusions
Both the desire to use, and the actual use of, the Internet to seek sexual health and HIV/AIDS information is high among secondary school students in Mbarara. The Internet may be a promising strategy to deliver low-cost HIV/AIDS risk reduction interventions in resource-limited settings with expanding Internet access.
A survey among 500 adolescent pupils in rural Uganda suggests widespread interest in online information about sexual health and HIV/AIDS. Over one-third of Internet users had already searched for relevant information online, and many of the others said they would like to educate themselves about HIV/AIDS online.
Editors' Summary
Background.
HIV/AIDS is a major health burden in sub-Saharan Africa, including Uganda. Despite a recent reduction of the number of HIV-infected individuals, HIV transmission remains a problem among Ugandan adolescents. Recent surveys suggest that about half of sexually active adolescents do not consistently use condoms, and that young people are less knowledgeable about HIV than they were 15 years ago.
Why Was This Study Done?
The Internet has a number of characteristics that make it an attractive tool in health education and HIV prevention, especially for adolescents—including interactivity, privacy, the overlap between education and play, and the ability to individualize information based on an initial assessment of background conditions, interest, and knowledge. It is also thought that despite these advantages, the Internet's potential in resource-poor settings with higher HIV infection rates and limited access to other health care resources has not been explored much. This study was done to gain some initial insights on the desired and actual use of the Internet to seek sexual health and HIV/AIDS information among adolescents in Uganda.
What Did the Researchers Do and Find?
They did a survey of 500 adolescent pupils randomly selected from five participating boarding schools in Mbarara, a small town in a rural part of Uganda. They asked three questions: To what extent are the adolescents exposed to computers and the Internet? Are they interested in accessing health information online? Who uses the Internet and how? Almost half of the participants said they had used the Internet at least once, and the majority said they had been online during the previous week. Most Internet users (82%) reported going online at school; 57% said they use Internet cafes, 17% access the Internet at home; and 11% at someone else's house. More than a third of all participants reported having used the Internet or computer to look up health information, and many had been looking for information on sexual health and HIV/AIDS. About two-thirds of the participants said that if Internet use were free, they would search for information on sexual health and HIV/AIDS prevention. The researchers analyzed the responses further to identify the most influential factors in whether one of the Internet users would go online to educate themselves about HIV/AIDS. They found that those participants who used the Internet more often and those who engaged in online activities like chat rooms, games, and e-mail, were more likely to search for HIV/AIDS information. On the other hand, those who went online only at school were less likely to do so.
What Do These Findings Mean?
Approximately the same proportion—roughly one-third—of adolescents in a rural setting in Uganda reported having used the Internet to look up health-related information as of young people in the United States. Together with the result that an additional third said that they would go online to educate themselves about HIV/AIDS if Internet use was free, this study suggests that initiatives in Africa to improve online access for adolescents as well as to develop content tailored for young people in specific settings would make a difference.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030433
Links page for adolescents and youth from HIV InSite at UCSF
Africa Initiative
HIV/AIDS education module from the US Public Broadcasting System
Lesson plan for “Using the Internet to Access Sexual Health Information” from the Information Institute of Syracuse
doi:10.1371/journal.pmed.0030433
PMCID: PMC1630714  PMID: 17090211
6.  HIV Behavioral Research Online 
Journal of Urban Health   2006;83(1):73-85.
Internet access has caused a global revolution in the way people of all ages and genders interact. Many have turned to the Internet to seek love, companionship, and sex, prompting researchers to move behavioral studies online. The sexual behavior of men who have sex with men (MSM) has been more closely studied than that of any other group online given the abundance of gay-oriented websites and concerns about increasing transmission of HIV and other sexually transmitted infections. Not only does the Internet provide a new medium for the conduct of behavioral research and for participant recruitment into an array of research studies, it has the as yet unrealized potential to reach huge numbers of MSM with innovative harm reduction and prevention messages tailored to individualized needs, interests, and risk behavior. Internet-based research on sexual behavior has many advantages in rapidity of recruitment of diverse samples which include individuals unreachable through conventional methods (i.e., non-gay identified and geographically and socially isolated MSM, etc.). Internet-based research also presents some new methodologic challenges in study design, participant recruitment, survey implementation, and interpretation of results. In addition, there are ethical issues unique to online research including difficulties in verifying informed consent, obstacles to surveying minors, and the ability to assure anonymity. This paper presents a review of Internet-based research on sexual behavior in MSM, a general discussion of the methodologic and ethical challenges of Internet-based research, and recommendations for future interdisciplinary research.
doi:10.1007/s11524-005-9008-3
PMCID: PMC2258323  PMID: 16736356
HIV transmission; Gay men; Internet; Ethics
7.  Facilitating the Recruitment of Minority Ethnic People into Research: Qualitative Case Study of South Asians and Asthma 
PLoS Medicine  2009;6(10):e1000148.
Aziz Sheikh and colleagues report on a qualitative study in the US and the UK to investigate ways to bolster recruitment of South Asians into asthma studies, including making inclusion of diverse populations mandatory.
Background
There is international interest in enhancing recruitment of minority ethnic people into research, particularly in disease areas with substantial ethnic inequalities. A recent systematic review and meta-analysis found that UK South Asians are at three times increased risk of hospitalisation for asthma when compared to white Europeans. US asthma trials are far more likely to report enrolling minority ethnic people into studies than those conducted in Europe. We investigated approaches to bolster recruitment of South Asians into UK asthma studies through qualitative research with US and UK researchers, and UK community leaders.
Methods and Findings
Interviews were conducted with 36 researchers (19 UK and 17 US) from diverse disciplinary backgrounds and ten community leaders from a range of ethnic, religious, and linguistic backgrounds, followed by self-completion questionnaires. Interviews were digitally recorded, translated where necessary, and transcribed. The Framework approach was used for analysis. Barriers to ethnic minority participation revolved around five key themes: (i) researchers' own attitudes, which ranged from empathy to antipathy to (in a minority of cases) misgivings about the scientific importance of the question under study; (ii) stereotypes and prejudices about the difficulties in engaging with minority ethnic populations; (iii) the logistical challenges posed by language, cultural differences, and research costs set against the need to demonstrate value for money; (iv) the unique contexts of the two countries; and (v) poorly developed understanding amongst some minority ethnic leaders of what research entails and aims to achieve. US researchers were considerably more positive than their UK counterparts about the importance and logistics of including ethnic minorities, which appeared to a large extent to reflect the longer-term impact of the National Institutes of Health's requirement to include minority ethnic people.
Conclusions
Most researchers and community leaders view the broadening of participation in research as important and are reasonably optimistic about the feasibility of recruiting South Asians into asthma studies provided that the barriers can be overcome. Suggested strategies for improving recruitment in the UK included a considerably improved support structure to provide academics with essential contextual information (e.g., languages of particular importance and contact with local gatekeepers), and the need to ensure that care is taken to engage with the minority ethnic communities in ways that are both culturally appropriate and sustainable; ensuring reciprocal benefits was seen as one key way of avoiding gatekeeper fatigue. Although voluntary measures to encourage researchers may have some impact, greater impact might be achieved if UK funding bodies followed the lead of the US National Institutes of Health requiring recruitment of ethnic minorities. Such a move is, however, likely in the short- to medium-term, to prove unpopular with many UK academics because of the added “hassle” factor in engaging with more diverse populations than many have hitherto been accustomed to.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In an ideal world, everyone would have the same access to health care and the same health outcomes (responses to health interventions). However, health inequalities—gaps in health care and in health between different parts of the population—exist in many countries. In particular, people belonging to ethnic minorities in the UK, the US, and elsewhere have poorer health outcomes for several conditions than people belonging to the ethnic majority (ethnicity is defined by social characteristics such as cultural tradition or national origin). For example, in the UK, people whose ancestors came from the Indian subcontinent (also known as South Asians and comprising in the main of people of Indian, Pakistani, and Bangladeshi origin) are three times as likely to be admitted to hospital for asthma as white Europeans. The reasons underpinning ethnic health inequalities are complex. Some inequalities may reflect intrinsic differences between groups of people—some ethnic minorities may inherit genes that alter their susceptibility to a specific disease. Other ethnic health inequalities may arise because of differences in socioeconomic status or because different cultural traditions affect the uptake of health care services.
Why Was This Study Done?
Minority ethnic groups are often under-represented in health research, which could limit the generalizability of research findings. That is, an asthma treatment that works well in a trial where all the participants are white Europeans might not be suitable for South Asians. Clinicians might nevertheless use the treatment in all their patients irrespective of their ethnicity and thus inadvertently increase ethnic health inequality. So, how can ethnic minorities be encouraged to enroll into research studies? In this qualitative study, the investigators try to answer this question by talking to US and UK asthma researchers and UK community leaders about how they feel about enrolling ethnic minorities into research studies. The investigators chose to compare the feelings of US and UK asthma researchers because minority ethnic people are more likely to enroll into US asthma studies than into UK studies, possibly because the US National Institute of Health's (NIH) Revitalization Act 1993 mandates that all NIH-funded clinical research must include people from ethnic minority groups; there is no similar mandatory policy in the UK.
What Did the Researchers Do and Find?
The investigators interviewed 16 UK and 17 US asthma researchers and three UK social researchers with experience of working with ethnic minorities. They also interviewed ten community leaders from diverse ethnic, religious and linguistic backgrounds. They then analyzed the interviews using the “Framework” approach, an analytical method in which qualitative data are classified and organized according to key themes and then interpreted. By comparing the data from the UK and US researchers, the investigators identified several barriers to ethnic minority participation in health research including: the attitudes of researchers towards the scientific importance of recruiting ethnic minority people into health research studies; prejudices about the difficulties of including ethnic minorities in health research; and the logistical challenges posed by language and cultural differences. In general, the US researchers were more positive than their UK counterparts about the importance and logistics of including ethnic minorities in health research. Finally, the investigators found that some community leaders had a poor understanding of what research entails and about its aims.
What Do These Findings Mean?
These findings reveal a large gap between US and UK researchers in terms of policy, attitudes, practices, and experiences in relation to including ethnic minorities in asthma research. However, they also suggest that most UK researchers and community leaders believe that it is both important and feasible to increase the participation of South Asians in asthma studies. Although some of these findings may have been affected by the study participants sometimes feeling obliged to give “politically correct” answers, these findings are likely to be generalizable to other diseases and to other parts of Europe. Given their findings, the researchers warn that a voluntary code of practice that encourages the recruitment of ethnic minority people into health research studies is unlikely to be successful. Instead, they suggest, the best way to increase the representation of ethnic minority people in health research in the UK might be to follow the US lead and introduce a policy that requires their inclusion in such research.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000148.
Families USA, a US nonprofit organization that campaigns for high-quality, affordable health care for all Americans, has information about many aspects of minority health in the US, including an interactive game about minority health issues
The US Agency for Healthcare Research and Quality has a section on minority health
The UK Department of Health provides information on health inequalities and a recent report on the experiences of patients in Black and minority ethnic groups
The UK Parliamentary Office of Science and Technology also has a short article on ethnicity and health
Information on the NIH Revitalization Act 1993 is available
NHS Evidences Ethnicity and Health has a variety of policy, clinical, and research resources on ethnicity and health
doi:10.1371/journal.pmed.1000148
PMCID: PMC2752116  PMID: 19823568
8.  Challenges of Internet Recruitment: A Case Study with Disappointing Results 
Background
The Internet provides tremendous opportunities for innovative research, but few publications on the use of the Internet for recruiting study participants exist. This paper summarizes our experiences from 2 studies in which we attempted to recruit teenagers on the Internet for a questionnaire study to evaluate a smoking-cessation website.
Objective
To evaluate strategies of recruiting teenagers for the evaluation of a smoking-cessation website through the Internet.
Methods
In Study 1 (Defined Community Recruitment), we sent invitation emails to registered members of a youth health website, CyberIsle. A total of 3801 email addresses were randomly divided into 2 groups. In the first group, emails indicated that the first 30 respondents would receive a Can $20 electronic gift certificate for use at an online bookstore if they would go to the Smoking Zine website and respond to a short survey. For the second group, the email also indicated that respondents would receive an additional Can $10 gift certificate if they referred their friends to the study. Reminder emails were sent 10 days after the sending of the initial invitation email. In Study 2 (Open Recruitment), we posted invitation messages on Web discussion boards, Usenet forums, and one specialized recruitment website, and attempted a snowball recruiting strategy. When potential participants arrived at the study site, they were automatically randomized into either the higher incentives group (Can $15 electronic gift certificate) or lower incentive group (Can $5 gift certificate).
Results
In Study 1 (defined community recruitment), 2109 emails were successfully delivered. Only 5 subjects (0.24%), including 1 referred by a friend, passed the recruitment process and completed the questionnaire; a further 6 individuals visited the information page of the study but did not complete the study. In Study 2 (open recruitment), the number of users seeing the advertisement is unknown. A total of 35 users arrived at the website, of whom 14 participants were recruited (8 from the Can $15 gift certificate group and 6 from the Can $5 gift certificate group). Another 5 were recruited from the general Internet community (3 from discussion boards and 2 from the Research Volunteers website). The remaining 9 participants were recruited through friend referrals with the snowball strategy.
Conclusions
Overall, the recruitment rate was disappointingly low. In our case, recruitment using Internet technologies including email, electronic discussion boards, Usenet forums, and websites did not prove to be an effective approach for soliciting young subjects to participate in our research. Possible reasons are discussed, including the participants' perspective. A major challenge is to differentiate trustable and legitimate messages from spam and fraudulent misinformation on the Internet. From the researchers' perspective, approaches are needed to engage larger samples, to verify participants' attributes, and to evaluate and adjust for potential biases associated with Internet recruitment.
doi:10.2196/jmir.7.1.e6
PMCID: PMC1550633  PMID: 15829478
Internet; data collection; World Wide Web; research subjects
9.  Using the Internet for Surveys and Health Research 
This paper concerns the use of the Internet in the research process, from identifying research issues through qualitative research, through using the Web for surveys and clinical trials, to pre-publishing and publishing research results. Material published on the Internet may be a valuable resource for researchers desiring to understand people and the social and cultural contexts within which they live outside of experimental settings, with due emphasis on the interpretations, experiences, and views of `real world' people. Reviews of information posted by consumers on the Internet may help to identify health beliefs, common topics, motives, information, and emotional needs of patients, and point to areas where research is needed. The Internet can further be used for survey research. Internet-based surveys may be conducted by means of interactive interviews or by questionnaires designed for self-completion. Electronic one-to-one interviews can be conducted via e-mail or using chat rooms. Questionnaires can be administered by e-mail (e.g. using mailing lists), by posting to newsgroups, and on the Web using fill-in forms. In "open" web-based surveys, selection bias occurs due to the non-representative nature of the Internet population, and (more importantly) through self-selection of participants, i.e. the non-representative nature of respondents, also called the `volunteer effect'. A synopsis of important techniques and tips for implementing Web-based surveys is given. Ethical issues involved in any type of online research are discussed. Internet addresses for finding methods and protocols are provided. The Web is also being used to assist in the identification and conduction of clinical trials. For example, the web can be used by researchers doing a systematic review who are looking for unpublished trials. Finally, the web is used for two distinct types of electronic publication. Type 1 publication is unrefereed publication of protocols or work in progress (a `post-publication' peer review process may take place), whereas Type 2 publication is peer-reviewed and will ordinarily take place in online journals.
doi:10.2196/jmir.4.2.e13
PMCID: PMC1761932  PMID: 12554560
Clinical Trials; Confidentiality; Data Collection; Ethics, Research; Evaluation Studies; Informed Consent; Internet; Patient Selection; Qualitative Research; Research Design; Selection bias; Survey research; Research Subjects
10.  Response Rate and Completeness of Questionnaires: A Randomized Study of Internet Versus Paper-and-Pencil Versions 
Background
Research in quality of life traditionally relies on paper-and-pencil questionnaires. Easy access to the Internet has inspired a number of studies that use the Internet to collect questionnaire data. However, Internet-based data collection may differ from traditional methods with respect to response rate and data quality as well as the validity and reliability of the involved scales.
Objective
We used a randomized design to compare a paper-and-pencil questionnaire with an Internet version of the same questionnaire with respect to differences in response rate and completeness of data.
Methods
Women referred for mammography at a Danish public hospital from September 2004 to April 2005, aged less than 67 years and without a history of breast cancer, were eligible for the study. The women received the invitation to participate along with the usual letter from the Department of Radiology. A total of 533 women were invited to participate. They were randomized to receive either a paper questionnaire, with a prepaid return envelope, or a guideline on how to fill in the Internet-based version online. The questionnaire consisted of 17 pages with a total of 119 items, including the Short Form-36, Multidimensional Fatigue Inventory-20, Hospital Anxiety and Depression Scale, and questions regarding social status, education level, occupation, and access to the Internet. Nonrespondents received a postal reminder giving them the option of filling out the other version of the questionnaire.
Results
The response rate before the reminder was 17.9% for the Internet group compared to 73.2% for the paper-and-pencil group (risk difference 55.3%, P < .001). After the reminder, when the participant could chose between versions of the questionnaire, the total response rate for the Internet and paper-and-pencil group was 64.2% and 76.5%, respectively (risk difference 12.2%, P = .002). For the Internet version, 97.8% filled in a complete questionnaire without missing data, while 63.4% filled in a complete questionnaire for the paper-and-pencil version (risk difference 34.5%, P < .001).
Conclusions
The Internet version of the questionnaire was superior with respect to completeness of data, but the response rate in this population of unselected patients was low. The general population has yet to become more familiar with the Internet before an online survey can be the first choice of researchers, although it is worthwhile considering within selected populations of patients as it saves resources and provides more complete answers. An Internet version may be combined with the traditional version of a questionnaire, and in follow-up studies of patients it may be more feasible to offer Internet versions.
doi:10.2196/jmir.9.3.e25
PMCID: PMC2047288  PMID: 17942387
Questionnaire design; random allocation; Internet; postal service; evaluation; data collection methodology
11.  Health Information–Seeking Behavior of Seniors Who Use the Internet: A Survey 
Background
The Internet is viewed as an important source for health information and a medium for patient empowerment. However, little is known about how seniors use the Internet in relation to other sources for health information.
Objective
The aim was to determine which information resources seniors who use the Internet use and trust for health information, which sources are preferred, and which sources are used by seniors for different information needs.
Methods
Questions from published surveys were selected based on their relevance to the study objectives. The Autonomy Preference Index was used to assess information needs and preferences for involvement in health decisions. Invitation to participate in this online survey was sent to the email list of a local senior organization (298 addresses) in the Netherlands.
Results
There were 118 respondents with a median age of 72 years (IQR 67-78 years). Health professionals, pharmacists, and the Internet were the most commonly used and trusted sources of health information. Leaflets, television, newspapers, and health magazines were also important sources. Respondents who reported higher use of the Internet also reported higher use of other sources (P<.001). Use of health professionals, pharmacists, leaflets, telephone, television, and radio were not significantly different; use of all other resources was significantly higher in frequent Internet users. When in need of health information, preferred sources were the Internet (46/105, 43.8%), other sources (eg, magazines 38/105, 36.2%), health professionals (18/105, 17.1%), and no information seeking (3/105, 2.8%). Of the 51/107 respondents who indicated that they had sought health information in the last 12 months, 43 sought it after an appointment, 23 were preparing for an appointment, and 20 were deciding if an appointment was needed. The source used varied by the type of information sought. The Internet was used most often for symptoms (27/42, 64%), prognosis (21/31, 68%), and treatment options (23/41, 62%), whereas health professionals were asked for additional information on medications (20/36, 56%), side effects (17/36, 47%), coping (17/31, 55%), practical care (12/14, 86%), and nutrition/exercise (18/30, 60%).
Conclusions
For these seniors who use the Internet, the Internet was a preferred source of health information. Seniors who report higher use of the Internet also report higher use of other information resources and were also the primary consumers of paper-based resources. Respondents most frequently searched for health information after an appointment rather than to prepare for an appointment. Resources used varied by health topic. Future research should seek to confirm these findings in a general elderly population, investigate how seniors seek and understand information on the Internet, and investigate how to reach seniors who prefer not to use the Internet for health information.
doi:10.2196/jmir.3749
PMCID: PMC4296102  PMID: 25574815
aged; aged, 80 and over; information-seeking behavior; Internet; patient education; empowerment
12.  Communications Between Volunteers and Health Researchers during Recruitment and Informed Consent: Qualitative Content Analysis of Email Interactions 
Background
While use of the Internet is increasingly widespread in research, little is known about the role of routine electronic mail (email) correspondence during recruitment and early volunteer–researcher interactions. To gain insight into the standpoint of volunteers we analyzed email communications in an early rheumatoid arthritis qualitative interview study.
Objectives
The objectives of our study were (1) to understand the perspectives and motivations of individuals who volunteered for an interview study about the experiences of early rheumatoid arthritis, and (2) to investigate the role of emails in volunteer–researcher interactions during recruitment.
Methods
Between December 2007 and December 2008 we recruited 38 individuals with early rheumatoid arthritis through rheumatologist and family physician offices, arthritis Internet sites, and the Arthritis Research Centre of Canada for a (face-to-face) qualitative interview study. Interested individuals were invited to contact us via email or telephone. In this paper, we report on email communications from 12 of 29 volunteers who used email as their primary communication mode.
Results
Emails offered insights into the perspective of study volunteers. They provided evidence prospectively about recruitment and informed consent in the context of early rheumatoid arthritis. First, some individuals anticipated that participating would have mutual benefits, for themselves and the research, suggesting a reciprocal quality to volunteering. Second, volunteering for the study was strongly motivated by a need to access health services and was both a help-seeking and self-managing strategy. Third, volunteers expressed ambivalence around participation, such as how far participating would benefit them, versus more general benefits for research. Fourth, practical difficulties of negotiating symptom impact, medical appointments, and research tasks were revealed. We also reflect on how emails documented volunteer–researcher interactions, illustrating typically undocumented researcher work during recruitment.
Conclusions
Emails can be key forms of data. They provide richly contextual prospective records of an underresearched dimension of the research process: routine volunteer–researcher interactions during recruitment. Emails record the context of volunteering, and the motivations and priorities of volunteers. They also highlight the “invisible work” of research workers during what are typically considered to be standard administrative tasks. Further research is needed to fully understand the role of routine emails, what they may reveal about volunteers’ decisions to participate, and their implications for research relationships—for example, whether they have the potential to foster rapport, trust, and understanding between volunteer and researcher, and ultimately shift the power dynamic of the volunteer–researcher relationship.
doi:10.2196/jmir.1752
PMCID: PMC3222195  PMID: 21997713
Emails; recruitment; informed consent; volunteer-researcher interactions; rheumatoid arthritis; qualitative research; motivations to volunteer; help-seeking; self-management
13.  Reliability of Internet- Versus Telephone-Administered Questionnaires in a Diverse Sample of Smokers 
Background
Smoking is more prevalent among lower-income individuals and certain racial/ethnic minorities. Addressing tobacco cessation among diverse populations is an urgent public health priority. As Internet use continues to rise among all segments of the US population, Web-based interventions have enormous potential to reach priority populations. Conducting Web-based smoking cessation research in priority populations requires psychometrically sound measurement instruments. To date, only one published study has examined the psychometric properties of Internet-administered measures commonly used in Web-based cessation trials. However, the sample was homogeneous with regard to race/ethnicity and income. We sought to replicate and extend these findings in a more diverse sample of smokers.
Objective
The aim was to examine the internal consistency and test-retest reliability of measures commonly used in smoking cessation clinical trials among racial/ethnic minorities and smokers with lower income.
Methods
Participants were enrolled in a randomized trial of the efficacy of an Internet smoking cessation program between June 2005 and September 2006. Following a baseline telephone assessment and randomization into the parent trial, participants were recruited to the reliability substudy. In phase I of recruitment, all participants in the parent trial were recruited to the substudy; in phase II, all consecutive racial/ethnic minority participants in the parent trial were recruited. Race and ethnicity were assessed via self-report using two standard items from the US Office of Management and Budget. An email was sent 2 days after the telephone assessment with a link to the Internet survey. Measures examined were quit methods, perceived stress, depression, social support, smoking temptations, alcohol use, perceived health status, and income. Internal consistency and test-retest reliability of Internet- versus telephone-administered measures were examined within four strata defined by race/ethnicity (non-Hispanic White, racial/ethnic minority) and annual household income (US $40,000 or less, more than $40,000).
Results
Of the 442 individuals invited, 319 participated (72% response rate): 52.4% were non-Hispanic White, 22.9% Black, 11.6% Hispanic, 7.8% Asian, 4.4% American Indian / Alaska Native, and 1% Native Hawaiian / Other Pacific Islander. About half (49.4%) reported an annual household income of US $40,000 or less, and 25.7% had a high school degree or less. Test-retest reliability was satisfactory to excellent across all strata for the majority of measures examined: 9 of 12 continuous variables had intraclass correlation coefficients ≥ 0.70, and 10 of 18 binary variables and both ordinal variables had kappa coefficients ≥ 0.70. Test-retest reliability of several quit methods varied across strata.
Conclusions
Race/ethnicity and income do not affect the psychometric properties of most Internet-administered measures examined. This knowledge adds to the confidence of conducting Web-based smoking cessation research and strengthens the scientific rigor of collecting information via the Internet on racial/ethnic minority and low-income subgroups.
Trial registration
clinicaltrials.gov NCT00282009 (parent trial)
doi:10.2196/jmir.987
PMCID: PMC2483847  PMID: 18364345
Reliability; smoking; Internet; diversity; measurement; psychometrics; minority groups; questionnaires; socioeconomic factors; social class; poverty; African Americans; Hispanic Americans
14.  Changes Over Time in the Utilization of Disease-Related Internet Information in Newly Diagnosed Breast Cancer Patients 2007 to 2013 
Background
As the number of people with Internet access rises, so does the use of the Internet as a potentially valuable source for health information. Insight into patient use of this information and its correlates over time may reveal changes in the digital divide based on patient age and education. Existing research has focused on patient characteristics that predict Internet information use and research on treatment context is rare.
Objective
This study aims to (1) present data on the proportion of newly diagnosed breast cancer patients treated in German breast centers from 2007 to 2013 who used the Internet for information on their disease, (2) look into correlations between Internet utilization and sociodemographic characteristics and if these change over time, and (3) determine if use of Internet information varies with the hospitals in which the patients were initially treated.
Methods
Data about utilization of the Internet for breast cancer–specific health information was obtained in a postal survey of breast cancer patients that is conducted annually in Germany with a steady response rate of 87% of consenting patients. Data from the survey were combined with data obtained by hospital personnel (eg, cancer stage and type of surgery). Data from 27,491 patients from 7 consecutive annual surveys were analyzed for this paper using multilevel regression modeling to account for clustering of patients in specific hospitals.
Results
Breast cancer patients seeking disease-specific information on the Internet increased significantly from 26.96% (853/3164) in 2007 to 37.21% (1485/3991) in 2013. Similar patterns of demographic correlates were found for all 7 cohorts. Older patients (≥70 years) and patients with <10 years of formal education were less likely to use the Internet for information on topics related to their disease. Internet use was significantly higher among privately insured patients and patients living with a partner. Higher cancer stage and a foreign native language were associated with decreased use in the overall model. Type of surgery was not found to be associated with Internet use in the multivariable models. Intraclass correlation coefficients were small (0.00-0.03) suggesting only a small contribution of the hospital to the patients’ decision to use Internet information. There was no clear indication of a decreased digital divide based on age and education.
Conclusions
Use of the Internet for health information is on the rise among breast cancer patients. The strong age- and education-related differences raise the question of how relevant information can be adequately provided to all patients, especially to those with limited education, older age, and living without a partner.
doi:10.2196/jmir.3289
PMCID: PMC4180359  PMID: 25158744
disease-related Internet information; digital divide; multilevel analysis; breast neoplasms; hospital differences
15.  An Experimental Study Using Opt-in Internet Panel Surveys for Behavioral Health Surveillance 
Objective
To present the design and preliminary results of a pilot study to investigate the use of opt-in Internet panel surveys for behavioral health surveillance.
Introduction
Today, surveyors in both the private and public sectors are facing considerable challenges with random digit dialed (RDD) landline telephone samples. The population coverage rates for landline telephone surveys are being eroded by wireless-only households, portable telephone numbers, telecommunication barriers (e.g., call forwarding, call blocking and pager connections), technological barriers (call-blocking, busy circuits) and increased refusal rates and privacy concerns. Addressing these issues increasingly drives up the costs associated with dual-frame telephone surveys designed to be representative of the target population as well as hinders their ability to be fully representative of the adult population of each state and territory in the United States.
In an effort to continue to meet these challenges head on and assist state and territorial public health professionals in the continued collection of data that are representative of their respective populations, novel approaches to behavioral health surveillance need continued examination. Both private and public sector researchers are evaluating the use of Internet opt-in panels to augment dual-frame RDD survey methods. Compared to dual-frame RDD, opt-in Internet panels offer lower costs, quick data collection and dissemination, and the ability to gather additional data on panelists over time. However, as with dual-frame RDD, this mode has similar challenges with coverage error and non-response. Nevertheless, survey methodologists are moving forward and exploring ways to reduce or eliminate biases between the sample and the target population.
Methods
A collaborative pilot project was designed to assess the feasibility and accuracy of opt-in Internet panel surveys for behavioral health surveillance. This pilot project is a collaboration between the CDC, four state departments of health, opt-in Internet panel providers and the leads of several large surveys and systems such as the Patient-Reported Outcome Measures Information System (PROMIS) and the Cooperative Congressional Election Study (CCES). Pilot projects were conducted in four states (GA, IL, NY, and TX) and four Metropolitan Statistical Areas (Atlanta, Chicago, New York City, and Houston). Data were collected using three different opt-in Internet panels and sampling methods that differ with respect to recruitment strategy, sample selection and sample matching to the adult population of each geography. A question bank consisting of 80 questions was developed to benchmark with other existing surveys used to assess various public health surveillance measures (e.g., the Behavioral Risk Factor Surveillance System, the PROMIS, National Survey on Drug Use and Health, and the CCES).
Results
We present comparative analyses that assess the advantages and disadvantages of different opt-in Internet panels sampling methodologies across a range of parameters including cost, geography, timeliness, usability, and ease of use for technology transfer to states and local communities. Recommendations for future efforts in behavioral health surveillance are given based on these results.
PMCID: PMC3692867
Random Digit Dialing; BRFSS; Survey Methods; Sample Matching; Representativeness
16.  Welcome Message from the Scientific Programme Committee 
It gives us great pleasure to welcome you to MEDNET99 - The 4th World Congress on the Internet in Medicine.
MEDNET99 is an international meeting which aims to bring together researchers, developers and users involved in the application of the Internet in Medicine. The Congress - this year under the theme "Towards the Millennium of Cybermedicine - will provide a forum for exploration of the rapidly developing relationship between medical sciences and the Internet, and is relevant to all medical and health care professionals, as well as those involved in the development and application of the new technological opportunities offered to the medical field by the Internet and the World Wide Web.
This year's Congress will take place over three full days, 19th - 21st September 1999, in the small and beautiful town of Heidelberg, one of the most famous tourist destinations in Germany and the town with the oldest German University.
MEDNET99 follows on from three successful MEDNET meetings, all held in the United Kingdom, which were attended by large international and multi-disciplinary groups of delegates. MEDNET98 was attended by more than 250 participants. After these three successful conferences in the United Kingdom, this year's MEDNET will for the first time be hosted outside of the UK. It will therefore hopefully be the first in a long series of World Congresses of Internet in Medicine hosted in different countries around the globe.
MEDNET99 will be preceded by several events on Saturday, 18th September: In a series of tutorials, experts in the field share their knowledge. To take account of local developments in the Internet scene we also organised a satellite symposium on "Internet and Medicine in Germany". A further novum is the "patient afternoon", where we bring together health care professionals with consumers to talk about medical information — in particular cancer information — on the Internet.
MEDNET99 will be focusing on the following themes:
applications of the Internet in medical information exchange and medical education
role of Internet and information exchange in evidence-based healthcare
use of the Internet for consumer health promotion and impact of the Internet on public health
global and regional health information networks
commercial information systems and portal sites for physicians
eJournals and scientific publishing on the Internet, online peer-review, impact of Internet on traditional medical publishing
telemedicine
search engines, search agents and other search tools
electronic mail
using the Internet for medical research and clinical trials
quality of Internet information
Internet usage statistics and demographics
clinical information systems and Intranets
system design issues
legal and ethical issues
As well as providing a forum for delegates to exchange valuable information, MEDNET99 will provide a varied program of social events and interesting workshops.
On behalf of the organisers and the Scientific Programme Committee of MEDNET99, we would like to extend a warm welcome to Heidelberg and we hope that you will all have a stimulating and rewarding Congress.
doi:10.2196/jmir.1.suppl1.e1
PMCID: PMC1761831
17.  Factors Associated With Intention to Use Internet-Based Testing for Sexually Transmitted Infections Among Men Who Have Sex With Men 
Background
Internet-based testing programs are being increasingly used to reduce testing barriers for individuals at higher risk of infection, yet the population impact and potential for exacerbation of existing health inequities of these programs are not well understood.
Objective
We used a large online sample of men who have sex with men (MSM) in Canada to measure acceptability of Internet-based testing and perceived advantages and disadvantages of this testing approach.
Methods
We asked participants of the 2011/2012 Sex Now Survey (a serial online survey of gay and bisexual men in Canada) whether they intended to use Internet-based testing and their perceived benefits and disadvantages of use. We examined whether intention to use was associated with explanatory variables spanning (A) sociodemographics, (B) Internet and technology usage, (C) sexually transmitted infections (STI)/ human immunodeficiency virus (HIV) and risk, and (D) health care access and testing, using multivariable logistic regression (variable selection using Bayesian information criterion).
Results
Overall, intention to use was high (5678/7938, 71.53%) among participants with little variation by participant characteristics. In our final model, we retained the variables related to (B) Internet and technology usage: use of Internet to cruise for sex partners (adjusted odds ratio [AOR] 1.46, 95% CI 1.25-1.70), use of Internet to search for sexual health information (AOR 1.36, 95% CI 1.23-1.51), and mobile phone usage (AOR 1.19, 95% 1.13-1.24). We also retained the variables for (D) health care access and testing: not “out” to primary care provider (AOR 1.24, 95% CI 1.10-1.41), delayed/avoided testing due to privacy concerns (AOR 1.77, 95% CI 1.49-2.11), and delayed/avoided testing due to access issues (AOR 1.65, 95% CI 1.40-1.95). Finally, we retained the variable being HIV positive (AOR 0.56, 95% CI 0.46-0.68) or HIV status unknown (AOR 0.89, 95% CI 0.77-1.01), age <30 years (AOR 1.41, 95% CI 1.22-1.62), and identifying as bisexual (AOR 1.18, 95% CI 1.04-1.34) or straight/other (AOR 0.67, 95% CI 0.50-0.90). The greatest perceived benefits of Internet-based testing were privacy (2249/8388, 26.81%), general convenience (1701/8388, 20.28%), and being able to test at any time (1048/8388, 12.49%). The greatest perceived drawbacks were the inability to see a doctor or nurse (1507/8388, 17.97%), wanting to talk to someone about results (1430/8388, 17.97%), not wanting online results (1084/8388, 12.92%), and low trust (973/8388, 11.60%).
Conclusions
The high and wide-ranging intention to use that we observed suggests Internet-based testing has the potential to reach into all subgroups of MSM and may be particularly appealing to those facing current barriers to accessing STI/HIV testing and who are more comfortable with technology. These findings will be used to inform the promotion and further evaluation of an Internet-based testing program currently under development in British Columbia, Canada.
doi:10.2196/jmir.2888
PMCID: PMC3841365  PMID: 24240644
homosexuality; male; Internet; testing; human immunodeficiency virus; sexually transmitted infection; health equity; patient acceptance of health care
18.  Recruitment to a Randomized Web-Based Nutritional Intervention Trial: Characteristics of Participants Compared to Non-Participants 
Background
Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll.
Objective
The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ.
Methods
The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment.
Results
Of 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame.
Conclusions
Relative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations.
Trial Registration
Clinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU)
doi:10.2196/jmir.1086
PMCID: PMC2762858  PMID: 19709990
Recruitment; Web-based interventions; making effective nutritional choices; Cancer Research Network; CRN; fruits and vegetables; research subject selection; selection; patient; mass screening; Internet; motivation; cultural diversity; health maintenance organizations
19.  Decisions to use complementary and alternative medicine (CAM) by male cancer patients: information-seeking roles and types of evidence used 
Background
Complementary and Alternative Medicine (CAM) is increasingly popular with cancer patients and yet information provision or discussion about CAM by health professionals remains low. Previous research suggests that patients may fear clinicians' 'disapproval' if they raise the subject of CAM, and turn to other sources to acquire information about CAM. However, little empirical research has been conducted into how cancer patients acquire, and, more importantly evaluate CAM information before deciding which CAM therapies to try.
Methods
Qualitative study, comprising semi-structured interviews with 43 male cancer patients of varying ages, cancer type and stage of illness, 34 of whom had used CAM. They were recruited from a range of NHS and non-NHS settings in Bristol, England.
Results
As a result of the lack of CAM information from health professionals, men in this study became either 'pro-active seekers' or 'passive recipients' of such information. Their main information resource was the 'lay referral' network of family, friends and acquaintances, especially females. 'Traditional' information sources, including books, magazines, leaflets and the media were popular, more so in fact than the internet. Views on the internet ranged from enthusiasm or healthy scepticism through to caution or disinterest. CAM information was generally regarded as 'empowering' as it broadened treatment and self-care options. A minority of participants were information averse fearing additional choices that might disrupt their fragile ability to cope. There was general consensus that CAM information should be available via the NHS, to give it a 'stamp of approval', which combined with guidance from informed health professionals, could help patients to make 'guided' choices. However, a small minority of these men valued the independence of CAM from the NHS and deliberately sought 'alternative' information sources and treatment options.
Men were selective in identifying particular therapies to use and sceptical about others, basing their choices on forms of 'evidence' that were personally meaningful: personal stories of individuals who had been helped by CAM; the long history and enduring popularity of some therapies; the plausibility of the mechanism of action; a belief or trust in individual therapies or their providers; scientific evidence. Scientific evidence ranked low in the men's personal decision-making about CAM, while it was recognised as important for NHS support for CAM.
Conclusion
These male cancer patients valued the support and guidance of 'trusted individuals' in making choices about CAM. Trusted health professionals could also play a significant role in helping patients to make informed choices. Any such dialogue must, however, acknowledge the different standards of evidence used by patients and clinicians to evaluate the benefits or otherwise of CAM therapies. Such open communication could help to foster an environment of mutual trust where patients are encouraged to discuss their interest in CAM, rather than perpetuate covert, undisclosed use of CAM with its attendant potential hazards.
doi:10.1186/1472-6882-7-25
PMCID: PMC2000907  PMID: 17683580
20.  The Internet and HIV study: design and methods 
BMC Public Health  2004;4:39.
Background
The Internet provides a new meeting ground, especially for gay men, that did not exist in the early 1990s. Several studies have found increased levels of high risk sexual behaviour and sexually transmissible infections (STI) among gay men who seek sex on the Internet, although the underlying processes are not fully understood. Research funded by the UK Medical Research Council (2002–2004) provided the opportunity to consider whether the Internet represents a new sexual risk environment for gay and bisexual men living in London.
Methods
The objectives of the Internet and HIV study are to: (i) measure the extent to which gay men living in London seek sexual partners on the Internet; (ii) compare the characteristics of London gay men who do and do not seek sex on the Internet; (iii) examine whether sex with Internet-partners is less safe than with other sexual partners; (iv) compare use of the Internet with other venues where men meet sexual partners; (v) establish whether gay men use the Internet to actively seek partners for unprotected anal intercourse; (vi) determine the potential for using the Internet for HIV prevention. These objectives have been explored using quantitative and qualitative research methods in four samples of London gay men recruited and interviewed both online and offline. The four samples were: (i) gay men recruited through Internet chat rooms and profiles; (ii) HIV positive gay men attending an NHS hospital outpatients clinic; (iii) gay men seeking an HIV test in an NHS HIV testing or sexual health clinic; (iv) gay men recruited in the community.
Results
Quantitative data were collected by means of confidential, anonymous self-administered questionnaires (n>4000) completed on-line by the Internet sample. Qualitative data were collected by means of one-to-one interviews (n = 128) conducted either face-to-face or on-line.
Conclusion
The strength of the Internet and HIV study is its methodological plurality, drawing on both qualitative and quantitative research among online and offline samples, as well as taking advantage of recent advances in web survey design. The study's findings will help us better understand the role of the Internet in relation to gay men's sexual practice
doi:10.1186/1471-2458-4-39
PMCID: PMC521483  PMID: 15341666
21.  Development and Evaluation of a Pedagogical Tool to Improve Understanding of a Quality Checklist: A Randomised Controlled Trial 
PLoS Clinical Trials  2007;2(5):e22.
Objective:
The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of nonpharmacological trials (CLEAR NPT).
Design:
Paired randomised controlled trial.
Participants:
Clinicians and systematic reviewers.
Interventions:
We developed an Internet-based computer learning system (ICLS). This pedagogical tool used many examples from published randomised controlled trials to demonstrate the main coding difficulties encountered when using this checklist.
Randomised participants received either a specific Web-based training with the ICLS (intervention group) or no specific training.
Outcome measures:
The primary outcome was the rate of correct answers compared to a criterion standard for coding a report of randomised controlled trials with the CLEAR NPT.
Results:
Between April and June 2006, 78 participants were randomly assigned to receive training with the ICLS (39) or no training (39). Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT. The mean paired difference and corresponding 95% confidence interval was 0.5 (−5.1 to 6.1). The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item. Combining both groups, the rate of correct answers was high or items related to allocation sequence (79.5%), description of the intervention (82.0%), blinding of patients (79.5%), and follow-up schedule (83.3%). The rate of correct answers was low for items related to allocation concealment (46.1%), co-interventions (30.3%), blinding of outcome assessors (53.8%), specific measures to avoid ascertainment bias (28.6%), and intention-to-treat analysis (60.2%).
Conclusions:
Although we showed no difference in effect between the intervention and control groups, our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct.
Editorial Commentary
Background: A key part of the practice of evidence-based medicine (essentially, the appropriate use of current best evidence in determining care of individual patients) involves appraising the quality of individual research papers. This process helps an individual to understand what has been done in a clinical research study, and to decipher the strengths, limitations, and importance of the work. Several tools already exist to help clinicians and researchers to assess the quality of particular types of study, including randomised controlled trials. One of these tools is called CLEAR NPT, which consists of a checklist that helps individuals to evaluate reports of nonpharmacological trials (i.e., trials not evaluating drugs but other types of intervention, such as surgery). The researchers who developed CLEAR NPT also produced an Internet-based computer learning system to help researchers use CLEAR NPT correctly. They wanted to evaluate to what extent this learning system helped people use CLEAR NPT and, therefore, carried out a randomised trial comparing the learning system to no specific training. A total of 78 health researchers were recruited as the “participants” in the trial, and 39 were randomised to each trial arm. Once the participants had received either the Internet training or no specific training, they used CLEAR NPT to evaluate reports of nonpharmacological trials. The primary outcome was the rate of “correct” answers that study participants gave using CLEAR NPT.
What the trial shows: The researchers found that the results on the primary outcome (rate of correct answers given by study participants) did not differ between the study arms. The rate of correct answers for individual items on the checklist also did not seem to differ between individuals receiving Internet training and those receiving no specific training. When looking at the scores for individual items, combined between the two study arms, participants scored highly on their appraisal of some aspects of trial design (such as generation of randomisation sequences and descriptions of blinding and the intervention) but poorly on other items (such as concealment of the randomisation sequence).
Strengths and limitations: Key strengths of this study include the randomised design and that the trial recruited enough participants to test the primary hypothesis. The failure to find a significant difference between study arms in this trial was likely not due to a lack of statistical power. One limitation of the study is that the group of researchers who participated were already fairly experienced in assessing trial quality at the start, and this may explain why no additional effect of the computer-based learning system was seen. It is possible that the training system may have some benefit for individuals who are less experienced in evaluating trials. A further possible limitation may be that there was a small imbalance at randomisation, with slightly more experienced researchers being recruited into the arm receiving no specific training. This imbalance might have underestimated the effect of the training system.
Contribution to the evidence: The researchers here report that this study is the first they are aware of that evaluates a computer-based learning system for improving assessment of the quality of reporting of randomised trials. The results here find that this particular tool did not improve assessment. However, the results emphasise that training should be considered an important part of the development of any critical appraisal tools.
doi:10.1371/journal.pctr.0020022
PMCID: PMC1865084  PMID: 17479163
22.  Expectations of Patients and Physicians Regarding Patient-Accessible Medical Records 
Background
Middle class populations have supported shared medical records, including Internet-accessible medical records. The attitudes of lower income populations, and of physicians, are less clear.
Objectives
The objective of this study was to compare the attitudes toward shared outpatient medical records among (1) socioeconomically disadvantaged patients in community health centers, (2) insured patients in primary care offices, and (3) a broad range of physicians in outpatient practice.
Methods
Written questionnaires were provided to patients in the waiting rooms of six primary care practices in the metropolitan Denver, Colorado area. Three practices were community health centers, and three practices were primary care clinics of an academic medical center. Questionnaires were also mailed to primary care physicians in the state of Colorado.
Results
There was a 79% response rate for patient surveys (601 surveys returned) and a 53% response rate for physician surveys (564 surveys returned). Academic medical center patients and community health center patients were equally likely to endorse shared medical records (94% vs 96%) and Internet-accessible records (54% vs 57%). Community health center patients were more likely than academic medical center patients to anticipate the benefits of shared medical records (mean number of expected benefits = 7.9 vs 7.1, P < .001), and they were also somewhat more likely to anticipate problems with shared records. Significant predictors of patient endorsement of Internet-accessible records were previous use of the Internet (OR = 2.45, CI 1.59–3.79), the number of expected benefits (OR = 1.12 per unit, CI 1.03–1.21), anticipation of asking more questions between visits (OR = 1.73, CI 1.18–2.54), and anticipation of finding the doctors' notes to be confusing (OR = 1.50, CI 1.01–2.22). Physicians were significantly more likely than patients to anticipate that access to records would cause problems. Physicians were significantly less likely than patients to anticipate benefits (mean number of expected benefits = 4.2 vs 7.5, P < .001).
Conclusions
Interest in shared medical records is not confined to a white, middle class population. Shared medical records are almost universally endorsed across a broad range of ethnic and socioeconomic groups. A majority of patients are also interested in Internet-accessible records, but a substantial minority is not. The primary determinants of support of Internet-accessible records are not age, race, or education level; rather, they are previous experience with the Internet and patients' expectations of the benefits and drawbacks of reading their medical records. Physicians have more concerns about shared medical records and see less potential for benefit. The attitudes of patients and physicians may need to be reconciled for widespread adoption of shared medial records to be achieved.
doi:10.2196/jmir.7.2.e13
PMCID: PMC1550642  PMID: 15914460
Patient access to records; medical records systems, computerized; questionnaires; physician-patient relations; medical records
23.  Estimating the size of the MSM populations for 38 European countries by calculating the survey-surveillance discrepancies (SSD) between self-reported new HIV diagnoses from the European MSM internet survey (EMIS) and surveillance-reported HIV diagnoses among MSM in 2009 
BMC Public Health  2013;13:919.
Background
Comparison of rates of newly diagnosed HIV infections among MSM across countries is challenging for a variety of reasons, including the unknown size of MSM populations. In this paper we propose a method of triangulating surveillance data with data collected in a pan-European MSM Internet Survey (EMIS) to estimate the sizes of the national MSM populations and the rates at which HIV is being diagnosed amongst them by calculating survey-surveillance discrepancies (SSD) as a measure of selection biases of survey participants.
Methods
In 2010, the first EMIS collected self-reported data on HIV diagnoses among more than 180,000 MSM in 38 countries of Europe. These data were compared with data from national HIV surveillance systems to explore possible sampling and reporting biases in the two approaches. The Survey-Surveillance Discrepancy (SSD) represents the ratio of survey members diagnosed in 2009 (HIVsvy) to total survey members (Nsvy), divided by the ratio of surveillance reports of diagnoses in 2009 (HIVpop) to the estimated total MSM population (Npop). As differences in household internet access may be a key component of survey selection biases, we analysed the relationship between household internet access and SSD in countries conducting consecutive MSM internet surveys at different time points with increasing levels of internet access. The empirically defined SSD was used to calculate the respective MSM population sizes (Npop), using the formula Npop = HIVpop*Nsvy*SSD/HIVsvy.
Results
Survey-surveillance discrepancies for consecutive MSM internet surveys between 2003 and 2010 with different levels of household internet access were best described by a potential equation, with high SSD at low internet access, declining to a level around 2 with broad access. The lowest SSD was calculated for the Netherlands with 1.8, the highest for Moldova with 9.0. Taking the best available estimate for surveillance reports of HIV diagnoses among MSM in 2009 (HIVpop), the relative MSM population sizes were between 0.03% and 5.6% of the adult male population aged 15–64. The correlation between recently diagnosed (2009) HIV in EMIS participants and HIV diagnosed among MSM in 2009 as reported in the national surveillance systems was very high (R2 = 0.88) when using the calculated MSM population size.
Conclusions
Npop and HIVpop were unreliably low for several countries. We discuss and identify possible measurement errors for countries with calculated MSM population sizes above 3% and below 1% of the adult male population. In most cases the number of new HIV diagnoses in MSM in the surveillance system appears too low. In some cases, measurement errors may be due to small EMIS sample sizes. It must be assumed that the SSD is modified by country-specific factors.
Comparison of community-based survey data with surveillance data suggests only minor sampling biases in the former that – except for a few countries - do not seriously distort inter-country comparability, despite large variations in participation rates across countries. Internet surveys are useful complements to national surveillance systems, highlighting deficiencies and allowing estimates of the range of newly diagnosed infections among MSM in countries where surveillance systems fail to accurately provide such data.
doi:10.1186/1471-2458-13-919
PMCID: PMC3850943  PMID: 24088198
Men having sex with men; MSM population size; Internet survey; Surveillance systems; HIV diagnosis; Europe
24.  Analysis of Internet Usage Among Cancer Patients in a County Hospital Setting: A Quality Improvement Initiative 
JMIR Research Protocols  2014;3(2):e26.
Background
Cancer is one of the most common diseases that patients research on the Internet. The Commission on Cancer (CoC) recommended that Parkland Memorial Hospital (PMH) improve the oncology services website. PMH is Dallas County’s public health care facility, serving a largely uninsured, minority population. Most research regarding patient Internet use has been conducted in insured, Caucasian populations, raising concerns that the needs of PMH patients may not be extrapolated from available data. The PMH Cancer Committee, therefore, adopted a quality improvement initiative to understand patients’ Internet usage.
Objective
The objective of the study was to obtain and analyze data regarding patients’ Internet usage in order to make targeted improvements to the oncology services section of the institutional website.
Methods
A task force developed an 11-question survey to ascertain what proportion of our patients have Internet access and use the Internet to obtain medical information as well as determine the specific information sought. Between April 2011 and August 2011, 300 surveys were administered to newly diagnosed cancer patients. Multivariate analyses were performed.
Results
Of 300 surveys, 291 were included. Minorities, primarily African-American and Hispanic, represented 78.0% (227/291) of patients. Only 37.1% (108/291) of patients had Internet access, most (256/291, 87.9%) having access at home. Younger patients more commonly had Internet access, with a mean age of 47 versus 58 years for those without (P<.001). Education beyond high school was associated with Internet access (P<.001). The most common reason for Internet research was to develop questions for discussion with one’s physician. Patients most frequently sought information regarding cancer treatment options, outcomes, and side effects.
Conclusions
Less than one-half of PMH oncology patients have Internet access. This is influenced by age, educational level, and ethnicity. Those with access use it to obtain information related to their cancer diagnosis. The most effective way of addressing our patients’ needs using the institutional website is to provide links to reputable disease-specific sites.
doi:10.2196/resprot.2806
PMCID: PMC4034116  PMID: 24824330
Internet; cancer; quality; quality improvement; patient education
25.  Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system 
Background
Cancer survivors can face significant physical and psychosocial challenges; there is a need to identify and predict which survivors experience what sorts of difficulties. As highlighted in the UK National Cancer Survivorship Initiative, routine post-diagnostic collection of patient reported outcome measures (PROMs) is required; to be most informative, PROMs must be linked and analysed with patients' diagnostic and treatment information. We have designed and built a potentially cost-efficient UK-scalable electronic system for collecting PROMs via the internet, at regular post-diagnostic time-points, for linking these data with patients' clinical data in cancer registries, and for electronically managing the associated patient monitoring and communications; the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system. This study aims to test the feasibility of the ePOCS system, by running it for 2 years in two Yorkshire NHS Trusts, and using the Northern and Yorkshire Cancer Registry and Information Service.
Methods/Design
Non-metastatic breast, colorectal and prostate cancer patients (largest survivor groups), within 6 months post-diagnosis, will be recruited from hospitals in the Yorkshire Cancer Network. Participants will be asked to complete PROMS, assessing a range of health-related quality-of-life outcomes, at three time-points up to 15 months post-diagnosis, and subsequently to provide opinion on the ePOCS system via a feedback questionnaire. Feasibility will be examined primarily in terms of patient recruitment and retention rates, the representativeness of participating patients, the quantity and quality of collected PROMs data, patients' feedback, the success and reliability of the underpinning informatics, and the system running costs. If sufficient data are generated during system testing, these will be analysed to assess the health-related quality-of-life outcomes reported by patients, and to explore if and how they relate to disease, treatment and/or individual differences characteristics.
Discussion
There is currently no system in the UK for collecting PROMs online and linking these with patients' clinical data in cancer registries. If feasible, ePOCS has potential to provide an affordable UK-scalable technical platform to facilitate and support longitudinal cohort research, and improve understanding of cancer survivors' experiences. Comprehensive understanding of survivorship difficulties is vital to inform the development and provision of supportive services and interventions.
doi:10.1186/1472-6947-11-66
PMCID: PMC3212976  PMID: 22029686

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