Table 5.

Summary description of studies on monitoring in the reviewed randomized controlled trials of electronic symptom reporting^a.

Patient group	Trial and countryb	Participant characteristicsc	Study characteristicsd	Health service innovation: monitoring	Main findings and research targetse
Cancer
	Kearney et al [51]; (McCann et al [79]); UK	112 breast, lung, or colorectal cancer patients; >18 (mean 56) years; female 76.8%	Design: P + 2; outside/home Duration: 4 cycles of chemotherapy (12–16 weeks)	Management of chemotherapy-related toxicity Intervention: A mobile phone system (ASyMS) was used in the morning, evening, and at any time patients felt unwell on days 1–14 following their first 4 cycles of chemotherapy. Patients completed an electronic symptom questionnaire on their mobile, including reporting their temperature. Patients immediately received written feedback on the phone. Clinicians were advised to contact patients within 1 hour after receipt of a red alert. The system’s alert to physician was based on a risk model. Control: Received standard care.	Unclear primary outcome. 2 of the 6 symptoms measured (fatigue and hand–foot syndrome) showed statistical significance between the 2 randomized groups: higher reports of fatigue in the control group and lower reports of hand–foot syndrome in the control group. Research target: Health benefits
Respiratory and lung disease
	Chan et al [53]; and the small prestudy Chan et al [52]; USA	120 children with persistent asthma; 6-17 (mean in intervention: 10.2, in control: 9.0) years; female 37.5% (Chan et al [52]: 10 children)	Design: P + 2; outside/home Duration: 12 months	Internet-based monitoring and education of children with asthma Intervention: The Asthma In-Home Monitoring group received 3 in-person visits and Internet-based education. They reported asthma signs and symptoms daily. Peak flow videos were sent twice per week for 6 weeks and then once weekly. Case manager scored results based on standardized checklists. Control: Traditional in-person education and case management over 6 scheduled visits. Both groups: The case manager contacted patients by email (intervention) or telephone (control) twice per week for 6 weeks and once per week thereafter to review their information. The patients were able to contact the case manager by email (intervention) or telephone (control) whenever needed. Asthma education in both groups followed the same curriculum.	Unclear primary outcome (both studies). Virtual patients had higher metered-dose inhaler with valved holding chamber technique scores than did the office-based group at 52 weeks (94% vs 89%), had greater adherence to daily asthma symptom diary submission (35.4% vs 20.8%), had less participant time (636 vs 713 patient-months), and were older. Caregivers in both groups perceived an increase in quality of life and an increase in asthma knowledge scores from baseline. There were no other differences in therapeutic or disease control outcome measures. Research targets: Health benefits, patient centeredness, resource utilization
	Guendelman et al [54]; USA	134 children with asthma; 8–16 (mean in intervention: 12, in control: 12.2) years; female in intervention: 60%; in control: 63%	Design: P + 2; outside/home Duration: 3 months	Asthma outcomes and self-management behaviors Intervention: Health Buddy enabled children to assess and monitor their asthma symptoms and quality of life daily and to transmit this information to a nurse. A protocol based on clinical practice guidelines consisting of 10 questions was designed. Patients answered daily queries from a nurse by pressing 1 of 4 buttons. Patients received immediate feedback from the Health Buddy. Asthma facts and trivia questions, which changed daily, were included to pique children’s curiosity and enhance learning. Control: Participants used a standard asthma diary.	Primary: After adjusting for covariates, the odds of having any limitation in activity were significantly (P = .03) lower for Health Buddy children Secondary: The intervention group was also significantly (P = .01) less likely to report peak flow readings in the yellow or red zone or to make urgent calls to the hospital (P = .05). Self-care behaviors also improved far more for the intervention group. Research targets: Health benefits, patient centeredness
	Jan et al [55]; Taiwan	164 children with persistent asthma; 6–12 (mean in intervention: 10.9, in control: 9.9) years; female in intervention: 60.3%, in control: 63.2%	Design: P + 2; outside/home Duration: 3 months	Interactive asthma monitoring Intervention: With Blue Angel for Asthma Kids, children completed the electronic asthma diary and recorded symptoms, need for rescue medication, and PEFf values, preferably daily. The tool comprised a 3-color real-time warning system accompanied by a treatment plan. Patients were asked to follow instructions given by the computer and the physician; thereafter, the decision support system was used to check whether asthma had been brought under control. Physicians then instructed the patients by email or telephone to increase, decrease, or continue the usual treatment. (See Rasmussen et al [57] for a comparable intervention.) Control: Patients recorded the same PEF values and asthma symptoms on paper, and received the same optimal clinical care, education program (as part of usual care), and support from asthma management teams. Their written asthma diary was supplemented by instructions for self-management.	Unclear primary outcome. When the 2 groups were compared with regard to change from baseline, the children in the intervention group had a significant decrease of nighttime (P = .028) and daytime symptoms (P = .009) compared with the children in the control group. The adherence rates of therapeutic and diagnostic monitoring, global assessment of asthma control, knowledge of asthma self-management, and quality of life of caregivers were all significantly higher in the intervention group than in the conventional asthma care group. Research targets: Health benefits, patient centeredness
	Prabhakaran et al [56]; Singapore	120 asthma patients; mean age in intervention: 37, in control: 40 years); female in intervention: 65%, in control: 53%	Design: P + 2; outside/home Duration: 3 months	Asthma monitoring Intervention: Patients received text messages to assist with asthma management, daily for 2 weeks, thereafter weekly for 10 weeks. New data were compared with previous results, and the frequency of reliever use was analyzed by the server receiving the data. If the value was too high (preset threshold) or the patient did not reply to 3 consecutive messages, an alert email was sent to the asthma nurse. All alerts were verified by the asthma nurse through telephone contact with the patients. Control: Patients had no text messaging support.	Unclear primary outcome. Asthma-control test scores improved for 36 participants in the intervention group compared with 28 in the control group (P = .113). Number of nebulizations decreased in 54 participants in the control group compared with 50 in the intervention group (P = .053). Emergency room visits decreased in 57 participants in the control group compared with 51 in the intervention group (P = .063). Admission rates did not decrease in either group (P = .5). The mean response rate to the messages was 82%, and 92% in the intervention group were satisfied with the text messaging service. Research targets: Health benefits, health care costs, patient centeredness
	Rasmussen et al [57]; Denmark	300 asthma patients; 18–45 (mean 29.5) years; female 69%	Design: P + 3; outside/home Duration: 6 months	Asthma monitoring Intervention 1: Internet-based monitoring. Patients completed an electronic diary and recorded symptoms, need for rescue medication, and PEF values, preferably daily. The Internet action plan calculated the level of asthma control and offered the patient advice on what to do next by using a 3-color warning system (green, yellow, and red). If the patient scored red, an email was sent to the physician. The physician used a decision support system to decide the level of treatment. Physician instructed patients by email or telephone. (See Jan et al [55] for a comparable intervention.) Intervention 2: Specialist monitoring group were taught how to use a peak flow meter and a written action plan daily (comprising a 3-color warning system based on the symptom score and PEF values) to adjust their medication. Control: In the GP g group the GP assessed the patient’s asthma symptoms and test results and from this decided the patient’s need for pharmaceutical treatment. The patients in the GP group did not receive any treatment or information about asthma from the study physician.	Several primary outcomes: Treatment and monitoring with the Internet-based management tool led to more significant improvement in the Internet group than in the other 2 groups regarding asthma symptoms (Internet vs specialist: odds ratio2.64, P = .002; Internet vs GP: odds ratio 3.26; P < .001), quality of life (Internet vs specialist: odds ratio 2.21, P = .03; Internet vs GP: odds ratio 2.10, P = .04), lung function (Internet vs specialist: odds ratio 3.26, P = .002; Internet vs GP: odds ratio 4.86, P < .001), and airway responsiveness (Internet) vs GP: odds ratio 3.06, P = .02). Research target: Health benefits
	Willems et al [58]; (Willems et al [80]); the Netherlands	109 patients with mild to moderate asthma; 56 children 7–18 (mean 11) years, 53 adults ≥18 (mean 46) years; female 55.6%	Design: P + 2; outside/home Duration: 12 months	Nurse-led telemonitoring Intervention: Lung function values and symptoms registered at home twice daily on a portable handheld device (diaries) were transferred to the asthma nurse (main caregiver) monthly or when having asthma complaints. The nurse studied the data daily and classified the asthma following a stepwise intervention protocol. The nurse was allowed to decrease (after 3 months of stable asthma) or increase asthma medication by 1 step. Physician was consulted only if necessary. Control: Regular care.	Willems et al [58]: Primary: No significantly improved asthma-specific quality of life; secondary: no significant decrease of asthma symptoms or medical consumption (time and medication). Willems et al [80]: Higher mean health care costs per patient in the intervention group. A decrease in the price of the asthma monitor will substantially increase the probability of the program being cost effective. Research targets: Health benefits, resource utilization, health care costs
	Lewis et al [59] (Reduce health care use) and Lewis et al [60] (quality of life); UK	40 patients with moderate to severe COPDh who had completed at least 12 sessions of outpatient pulmonary rehabilitation; mean age in [59] in intervention: 67, in control: 70 years; mean age in [60] for intervention: 70, for control: 73 years; female 50%	Design: P + 2; outside/home Duration: 6 months + 6-month follow-up	Home telemonitors to reduce health care use [59], and improve quality of life for patients [60] Intervention: Patients received standard care plus Docobo HealthHUB handheld monitors at home for 26 weeks followed by 26 weeks of standard care (for observation and follow-up). During the monitoring period, patients recorded their symptoms and physical observations twice daily. Data were transmitted automatically at night via the home telephone line. Nurses could access the data through a website and receive alerting email messages if certain conditions were detected. Control: Standard care for 1 year.	Reduced health care use: Primary: No significant differences between the groups in hospital admissions [59]; Secondary: No significant differences between the groups in emergency room visits, days in hospital, or contacts with the specialist COPD community nurse team during the monitoring period, but fewer primary care contacts for chest problems (P < .03) in the intervention group [59]. After the monitors were removed, no significant differences were found between the groups for any of the health care contacts (P > .20 throughout) [59]. Quality of life: Primary: No significant differences in quality-of-life scores between the groups at any time, or consistently within either group over time [60]. Research targets: Health care costs, health benefits
	Nguyen et al [61]; USA	17 patients with moderate to severe and stable COPD; mean 68 (SD 11) years; female 65%	Design: P + 2; outside/home Duration: 6 months	A cell phone-based exercise persistence intervention postrehabilitation for COPD All participants developed an individualized exercise plan, were issued a pedometer and exercise booklet, and were trained to log their daily exercise and symptoms. Intervention: MOBILE-coached patients submitted symptoms and exercise daily, and received immediate summary feedback from server and weekly reinforcement feedback by text message from nurse; reports of worsening symptoms were automatically flagged to the nurse for follow-up. Control: MOBILE self-monitored: Entered and submitted the same information on the cell phone, but no (information and) alarm to nurse and no coaching feedback from nurse.	Unclear primary outcome. Small feasibility study. Logging exercise and symptoms was easy, and keeping track of their exercise helped patients remain active. There were no significant differences between groups over time in maximal workload, 6-minute walk distance, or health-related quality of life (P > .05); however, MOBILE-self-monitored increased total steps per day, whereas MOBILE-coached logged fewer steps over 6 months (P = .04). Research targets: Health benefits, patient centeredness
Cardiovascular disease
	Carrasco et al [62]; Spain	38 GPs, 285 hypertensive patients; (age range not reported), mean 62 years; female 40%	Design: P + 2; outside/home Duration: 6 months	Text message-based Patient–GP interaction on control of hypertension Intervention: Patients sent the mean results of blood pressure self-monitoring 4 times a week, and heart rate and body weight once a week. They could complete an optional questionnaire during each wireless application protocol session. GPs accessed the data sent via the Web and could send a text message regarding any related issue to the patient’s phone. Control: Followed the same protocol, except that they recorded the data on paper and could only deliver it to their GP personally at the routine visits.	Primary: The influence of the interaction between patient and GP, in a nonspecialized setting, in the selected type of hypertensive patients, did not significantly improve the degree of hypertension control; Secondary: the course of hypertension during follow-up, adherence to the protocol, results of quality-of-life and anxiety questionnaires, or economic aspects such as the number of consultations or hospital admissions did not significantly improve. Research targets: Patient centeredness, health benefits, health care costs
	Santamore et al [63]; USA	321 cardiovascular disease patients; 18–85 (mean in intervention: 62, in control: 63.2) years; female % not reported	Design: P + 2; outside/home Duration: 8 months	Telemedicine System to Decrease Cardiovascular Disease Risk All patients received a manometer with memory and a pedometer. Intervention: Patients exchanged data with their care provider via the Internet. Patient could enter data daily, or for several days at once. Patients reported weight, blood pressure and heart rate, physical activity (steps/day), and cigarette smoking, and received feedback on cardiovascular disease risk reduction. Data for 10–15 patients were presented simultaneously on the provider screen. Out-of-limits parameter (red) values were presented first. Control group received usual care plus manometer and pedometer.	Unclear primary outcome. Systolic and diastolic blood pressures decreased significantly in both groups. The decreases in systolic blood pressure were greater in the intervention group (P < .05). For both groups, low-density lipoprotein decreased and high-density lipoprotein remained unchanged. In diabetic patients, blood glucose and glycated hemoglobin decreased significantly (P < .01) only in the intervention group. In nondiabetic patients, the risk of diabetes and metabolic syndrome score decreased (P < .01) only in the intervention group. Rates of usage of the telemedicine system were very high (92%). This rate of self-monitoring greatly exceeded the self-monitoring rate in controls (48%). The telemedicine-entered blood pressure values were similar to the meter-recorded values and to the office values. Research targets: Health benefits, patient centeredness
	Schwarz et al [64]; USA	102 heart failure patients; 65–94 (mean 78.1) years; female 52%	Design: P + 2; outside/home Duration: 3 months	Telemonitoring of heart failure patients and their caregivers Intervention: e-Cardiocom electronic home monitoring system measured weight daily. The device asked the participants to answer yes or no to questions about symptoms. The heart failure care manager, an advanced practice nurse, was responsible for daily monitoring of parameters. Measurements outside of prescribed parameters were automatically displayed, resulting in the nurse calling the caregiver in the dyad to further assess the situation, provide education, and update the medication regimen. The nurse notified the primary physician or cardiologist about the patient’s status as needed. Control group: Usual care.	Several primary outcomes (reducing subsequent hospital readmission, emergency department visits, and cost; and increasing the time between discharge and readmission). There were no significant differences due to telemonitoring for any outcomes. Research targets: Health care costs

^a Articles were identified in a comprehensive search in Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore from 1990 to November 2011, and were published in the time period 2002–2011.

^b Main author, main reference. References with and between them are articles that belong to the same study. References in brackets contributed relevant study information on the study in question.

^c Number of clinicians, number of patients with diagnosis, age range (mean) of patients, percentage female patients.

^d Design (P = parallel group design, CO = crossover, C = cluster, F = factorial, O = other, U = unclear; + number of study arms), where symptom reporting took place (outside or in the home; or inside a clinic), and duration of intervention.

^e Main findings are in general presented as in the original article and refer to primary outcome if clearly defined and secondary outcomes considered relevant for the scope of the study. Research targets refers to the six areas of health service quality defined by the Institute of Medicine [43].

^f Peak expiratory flow rate.

^g General practitioner.

^h Chronic obstructive pulmonary disease.