We pre-tested the web-based e-Diary for self-monitoring of pain and symptoms and then pilot tested it in two small groups of children and adolescents with sickle cell disease. We found that the participants were able to record pain and symptoms on the e-Diary using the smartphone. The smartphone was easy to use and efficient to complete (<5 minutes). Changes and revisions were made after the pretesting which improved the responsiveness of the screens to touch, navigation, functionalities (submit, clear, cursor movement), visual appearance and layout. Data showed that the participants were able to accurately (80%) enter items from pre-completed paper-based measures to the web-based e-Diary accessed by using the smartphone. In items with less than 100% accuracy, participants may have made their markings based upon their own signs and symptoms in the previous 12 hours, rather than from the paper based measures. For example, on the screen with “Check if you experienced any of the following signs and/or symptoms over the last 12 hours,” they marked negatively based on their own symptoms, rather than the symptom (e.g. fever) that was marked on the paper based measures.
The e-Diary was also used by children and adolescents to describe their own pain and symptoms, sleep, and thoughts and feelings over the previous 12 hours. Data were downloaded immediately to an Excel spreadsheet and imported readily into a statistical software program. The simple download allows immediate analyses of data, which is a major advantage when compared to traditional paper-based measures. Therefore, data may be monitored in real time by clinicians and researchers enhancing the opportunity to detect health problems early. The direct download of data into the analysis program also minimized the errors, personnel cost, and time delay associated with having to enter data from paper based measures.
The overall pain intensity reported by participants was mild (2.0 on 0 to 10 scale), which was lower than previous reports of overall pain intensity in adult patients (4.5 on 0 to 9 scale) who completed daily diaries at home (49
) when they participated in the Pain in Sickle Cell Epidemiology (PiSCES). It is interesting to note that one of the most commonly reported symptoms was feeling tired and, yet the mean sleep score was 8.1 (0=did not sleep at all to 10=slept a lot). The feeling of being tired was accompanied by yellowing of the eyes, paleness, general weakness, and irritability. It is therefore possible that some participants may have low steady state hemoglobin that may explain the feeling of being tired. Because the pain intensity ratings were mild and ibuprofen was the pain medication reported, the feeling of being tired was not likely related to narcotic administration. Participants were specifically invited by the Sickle Cell Disease Foundation of California (SCDFC), a community based organization. Therefore, the pain and symptoms experiences may be different from a normative sample, and may not be representative of children and adolescents with SCD who have more or less frequent pain episodes at home and/or who were routinely receiving follow-up services in comprehensive medical centers.
To our knowledge, the web-based e-Diary was currently the only one available for children and adolescents with SCD that includes measures of the multiple dimensions of pain (i.e. intensity, location, quality descriptors for affective, evaluative, sensory, and temporal dimensions). A unique feature of the web-based e-Diary was that it included items specific to sickle cell disease, such as symptoms that may potentially trigger pain episodes (21
), and pain medications that were not typically included in previously reported e-Diaries (5
). Previous studies of e-Diaries utilized the Children’s Symptom Inventory (CSI), with 35 symptoms. Some of these symptoms were not applicable to SCD, and items that were highly relevant to SCD, such as pain with urination, and pain in the genitals were not included in the CSI (6
Previous studies in SCD have used paper pain diaries which asked participants to report similar questions to the web-based e-Diary used in our study. For example, McClish and colleagues (49
) used a paper pain diary in adults in the Pain in Sickle Cell Epidemiology Study (PiSCES). The PiSCES diary was modeled after the one used in the Multicenter Study of Hydroxyurea (50
). The paper pain diary (49
) asked patients to record daily 1) worst sickle cell pain intensity, on a scale from 0 (none) to 9 (unbearable), 2) whether or not they were in a sickle cell crisis, and 3) whether they had gone for an unscheduled physician visit, emergency department (ED) visit or were hospitalized due to sickle cell pain. Our e-Diary was different in that we used a 10-unit metric as a measure of pain intensity. The 0 to 10 metric was commonly used by clinicians when assessing pain. Von Baeyer and colleagues (26
) recommended that all pediatric pain scales have a 10-unit metric so as to decrease confusion from the many differing numerical values. Our e-Diary also included other dimensions of pain (location, evaluative, affective, sensory, temporal quality), as well as other factors that could affect the overall pain ratings such as fluids, sleep, thoughts/feelings, symptoms, medications and other strategies used for pain.
The diary used in the PiSCES study (49
) also asked adult participants to mark a body chart, indicating where they hurt. However, the analyses were limited to the number of participants marking a specific body area and the number of body areas marked as done in other pain studies (7
), and did not account for change in body surface area. In our web-based e-Diary, not only the number of body location but also the surface area could be marked and was also quantifiable by percentage of body surface area (). We believed this was important, since our previous data (20
) in children and adolescents with SCD showed that although the intensity may not change significantly, the spatial distribution of the pain changed daily (up to 50% to 60%). Participants were able to highlight portions of a body area that were painful; but the segments were preserved from the original paper-based measure. Therefore the markings may not truly represent the depth and specific markings within a segmented area. However, the electronic percentage calculation of the segmented area represented a proportion from the total body outline and could be reflective of the pain areas in the body. Although pain quality descriptors were selected on separate screens of the e-Diary to describe quality of pain, participants were not be able to indicate descriptive pain terms to the different sites on the body outline.
In contrast to previous studies that utilized a 7-point cartoon type faces pain scale (7
), our study used a VAS that was anchored by “none”
, with the scale starting at “none”
. The VAS in the e-Diary was based on word anchors of “none” to “worst pain” which does not display numbers. The VAS allows participants a wider range of responses to rate their current, worst, and least pain, without the use of numbers that limits responses to the number 10. A disadvantage is that cartoon type faces scale can be used by younger children while the VAS would have to be used by schoolage children that were tested. However, it is very unlikely that younger children than those who participated in the study will be expected to self-monitor pain and symptoms using the smartphone. Similar to our study, McClellan and colleagues (5
) used a smartphone to ask participants with SCD to record daily pain using an e-diary. However, it only had a few items to assess the morning and evening pain, followed by questions about sleep quality, functional limitations, and use of the coping skills program. The pain diary was limited to pain intensity, without assessing other dimensions (location on a body outline diagram, quality), other symptoms, or medications and other strategies.
Our study utilized a smartphone device that would allow similar features as personal digital assistants (PDAs) that were previously reported in the literature (7
). Additional features of the smartphones include the ability to make direct phone calls, access resources on the internet, and also send/receive text messages to clinicians as well as peers. The smartphone may potentially facilitate communication in a more timely manner than the typical paper-based measures and allow immediate contact with care providers in ways that were not previously possible. Furthermore, smartphone devices are more commonly used than PDAs. The smartphone allows for the development of web-based applications that overcome the issue of developing phone specific programs. Because smartphones use finger touch, they do not require a stylus or pen, which may potentially break or be lost.
We did not encounter technical problems, such as not being able to connect to internet, loss of data, or data not transmitting to the server during either of the two pilot studies. However, it is possible that these technical problems may be encountered once the smartphones are used in naturalistic settings (home, school, hospital). The smartphone device may be lost, and power failures and damage to the unit may occur (6
). To minimize loss of data, the e-Diary was designed so that data were immediately transmitted using wireless connection. Therefore, we anticipate that data would not be lost even if the device was lost, or broken afterwards.
We were using the smartphone as part of a wireless pain intervention program in a larger study of children and adolescents with SCD. The program allowed them to self-monitor their symptoms. The program also allowed a health care provider to track symptoms remotely over time. An algorithm was pre-programmed in such a way that an alert message was sent to the health care provider: 1) immediately for e-diary entries of symptoms requiring immediate attention such as fever, changes in breathing, painful erection, severe pain (rating of 8 or more on the on the 0 to 10 VAS); 2) if symptoms were checked in three consecutive entries (an equivalent of having unrelieved symptoms for 24 hours), for symptoms not requiring immediate attention, but which may be potentially serious; 3) if symptoms were checked in five consecutive entries (an equivalent of having the symptoms checked for 48 hours), for symptoms not requiring immediate attention, but which may potentially lead to sickle cell related complications. The healthcare provider was responding and making appropriate referrals to an emergency department or hematology clinic when needed. Furthermore, the healthcare provider offered clinical guidance (individually tailored treatments based on standardized algorithms), as well as promoted patient-care provider communication and patient self-care management in a timely manner (36
The American Society of Pediatric Hematology/Oncology Sickle Cell Summit recommended optimizing access to care and pain treatments from knowledgeable health care providers, such as hematologists and pain specialists (39
). The web-based e-Diary may improve pain management for children and adolescents with SCD who are at increased risk for under-treatment and disruption in activities of daily living due to pain (40
). The handheld wireless technology, such as the smartphone, may potentially minimize barriers (e.g. lack of transportation to comprehensive centers and access to knowledgeable providers) that not only limit access to hospital and clinic based interventions, but also lead to treatment delays (3
In conclusion, this study provides support for the usability of smartphones to access a web-based e-Diary for self-monitoring of pain and symptoms in children and adolescents with SCD. Usability testing is a procedure used for evaluating technology using a small sample of users (2 to 3 initially, 4 to 8 to drive a useful iterative cycle) to identify technical performance problems, determine time to complete, ease of use, and incorporate user feedback and comments during development (45
This study also provided support for the feasibility of using the smartphones in children and adolescents with sickle cell disease, who pilot tested the e-Diary using the smartphone by describing the pain and symptoms experienced the previous 12 hours. Smartphones may be critical to improve communications between individuals with SCD and health care providers, to increase accessibility and acceptability of distance treatment programs (5
), and teach children and adolescents about self-monitoring of pain and symptoms, so that they may be addressed in a timely manner to minimize delay in seeking treatment. The majority of children and adolescents were able to access online information, making smartphones an excellent medium to deliver health promotion and preventive treatment strategies (42
Electronic diaries were used in children as young as six years for measurement of symptoms and behaviors in children with recurrent and chronic pain (7
). We currently use the smartphones to access the web-based e-Diary in the Wireless Pain Intervention Program for at Risk Youths with Sickle Cell Disease. The smartphone may be particularly useful for those children and adolescents with sickle cell disease who are more severely affected by the disease and frequently use the health care system. Wireless technology may potentially be a cost-effective method for measuring health outcomes, engaging participants in self-monitoring and self-management behavioral interventions, and timely communication between patient and healthcare providers. A major benefit of wireless technology is the automatic data transfer which may potentially improve frequency and contact between the patient and health care providers, and consequently minimize delay in treatments and health care costs associated with ED visits and hospitalizations (47