Objective. Chronic pain is a common and costly syndrome which affects approximately one in three US adults. Factors such as shortened length of the medical visit, increased availability of technological approaches to care, and a more informed patient all suggest that a new paradigm is required for chronic pain management. Although much has been written about the use of electronic diaries in clinical trials, little has been presented about the use of these diaries in clinic practice and their potential for changing pain behavior. The intent of this preliminary study is to measure accessibility and usability of a software program designed for use on a personal digital assistant and to discuss how the software program may impact clinic practice and patient behavior.
Methods. We present the results of a preliminary, randomized, comparison, crossover trial of 36 chronic pain patients who were asked to monitor their pain, mood, activity interference, medication use, and pain location on either a paper or electronic diary for 2 weeks. Patients in the electronic diary condition were able to observe changes in their ratings over time and view them on a secure web site.
Results. No differences were found between paper and electronic tracking on pain descriptors, pain interference, mood, or helpfulness of medication. Similar to past findings, patients found the electronic diary easier to use (P < 0.0001) and would continue using it (P < 0.05) over paper if given the choice. Importantly, patients using the electronic diary reported more frequently that a provider suggested medication change (P < 0.05) based on feedback from the electronic diary. One trend requiring further investigation is that electronic diary users reported that the diary enabled them and their doctor to make care adjustments according to changes in pain status.
Conclusion. This study goes beyond previous research on preference and data quality to investigate how the information provided may affect patient and physician perspectives toward pain management. Although not the initial intent of this study, findings indicate that electronic tracking may provide information which can affect management decisions. A follow-up study is ongoing to investigate these initial results. If found to be true, electronic monitoring may have broad implications for health care, policy, and improvement in quality of care for chronic pain sufferers in the future.
Chronic pain symptoms are pervasive, with prevalence ratings as high as a third of the population . Pain is the primary symptom that prompts individuals to seek medical attention , but despite its prevalence, it remains a stubborn condition to treat and a difficult concept to capture by objective measurement techniques. While chronic pain is typically not considered “curable,” one of the main concerns in managing chronic pain is identifying the core problem and exacerbating factors in order to minimize chronicity.
Recent trends within health maintenance organizations have encouraged primary care physicians (PCPs) to take greater responsibility in monitoring and treating patients with intractable pain . Despite the emphasis on pain control, these physicians often have had limited training in pain and have the added burden of treating chronic pain patients within a busy clinic practice [4,5]. Treatment decisions often have to be made on the basis of ever briefer clinic encounters. PCPs frequently express frustration because they are unable to devote the necessary time to obtain accurate and thorough information [6,7]. One important result of brief encounters is that time spent with patients is often focused on medical interventions, and less on addressing behavior and lifestyle changes. Further, busy clinicians have limited time to engage in discussion about other (seemingly) unrelated psychosocial issues that may have a tendency to exacerbate pain. Patients often feel neglected and misunderstood because no one is closely attending to their condition, or spending time to address underlying symptoms [8,9]. Patients and physicians alike become ever more frustrated by pain symptoms requiring repeated visits that produce limited improvement . Often this leads patients to use already stressed emergency room services when pain becomes unbearable—chronic pain accounts for 21% of emergency room visits and 25% of annual missed work days—or to require frequent office visits [11,12]. As a result, chronic pain imposes a greater economic burden than any other disease [1,13,14].
In response to these concerns, there has been a revolution within the medical community in regard to patient perceptions about their health status, and this includes the evaluation of pain symptoms before, during, and after treatment. More and more patients are informed about their medical care and access information about their condition over the Internet. As more individuals become comfortable with the use of electronic devices and new technologies, this trend will intensify. The Internet provides an increasingly sophisticated electronic referral system, which many patients utilize to seek medical help [15,16]. Information obtained through the Web shapes decisions that were once solely the responsibility of the physician. As a result, patients may bring expectations about pain management to the medical visit which had previously been left to the provider. Self-assessment and monitoring are key elements of patient care where patients may wish to play a more interactive role. These assessments must be accurate, reliable, inexpensive, easy to use, timely, and acceptable to patients and clinicians, given the current time constraints on medical visits. Interest lies in how these requirements can be met by using modern electronic diaries. Little research has investigated whether electronic diaries can potentially save clinicians time, ensure completeness and accuracy of responses, and positively impact diagnoses and treatment by making results immediately available to the clinician and patient.
Considerable research has been conducted on tracking chronic pain using paper diaries. Understanding pain patterns through paper diary tracking has long been considered a key aspect of pain management. One concern that is often raised by physicians is poor compliance with keeping paper diary entries. Past studies have found that patients using electronic diaries were more compliant than those using paper, and had higher satisfaction over the course of the trial [17–19]. Only recently, with the increase and ease of electronic data monitoring, have tablet personal computer and personal digital assistant (PDA) tracking become potentially useful tools in the management chronic pain. Research to date widely supports the use of electronic data tracking over paper diaries for a variety of medical conditions such as asthma, cancer, back pain, and rheumatoid arthritis [20–25]. Numerous studies have evaluated the use of electronic Visual Analog Scale (VAS) scales, assessed their psychometric properties and patient comfort, and compared electronic versions to paper diaries [17,26–30]. What has not been researched is whether this technology has the potential to improve patient care, both from the patient's and the practitioner's perspective. Many of these studies conclude that electronic tracking is preferred and improves data quality and that they have promising applications for future use but require additional research. Few studies investigate whether electronic tracking allows patients and physicians to more easily identify factors exacerbating or relieving pain, encourages patients or physicians to modify treatment, or helps patients to better understand their symptoms and symptom management. Also, little research has determined whether there are economic advantages to electronic data tracking and whether it facilitates better use of time during the clinic visit with the physician.
The purpose of this article is to explore the importance of electronic tracking as a core component of future pain management. We present results from a preliminary, randomized, crossover trial comparing paper and electronic tracking, and speculate on the potential implications for understanding chronic pain through the use of electronic monitoring, barriers with electronic tracking, and impact on the physician–patient interaction. We also describe elements of an ongoing follow-up study investigating some of these important questions.
This study was approved by the Human Subjects Committees of New England Research Institutes and Brigham and Women's Hospital. Subjects for this study were adults who attended an urban pain management center in an academic teaching hospital. All subjects were over 21 years of age, English-speaking, and experiencing chronic pain for longer than 3 months. Participants were recruited through flyers placed in the pain clinic and were requested to call a 1–800 number for eligibility screening. Patients were also invited to participate while attending the pain management center. Exclusion criteria included obvious cognitive impairment, inability to speak or read English (all screens were in English), age younger than 21, and no access to a landline telephone (cell phones as a sole contact point prohibited ability to transmit data). All patients were required to sign (electronically) an Institutional Review Board approved online informed consent prior to participation. Participants who completed the study were reimbursed $50 for their effort.
All participants were asked to complete either a paper or electronic diary questionnaire in a randomized crossover design. Once eligibility was determined, participants were provided a unique username and password and were instructed to complete an online consent form to enroll in the study. For this study, all participants reported that they had access to the Internet either at home or at work. Participants were randomly assigned to receive one of the two experimental conditions. In condition A, participants were assigned to complete daily paper diaries over a 2-week period, followed by completing an electronic diary over a 2-week period. In condition B, participants completed a daily electronic diary for 2 weeks, followed by a daily paper diary for a 2-week period. After completion of each condition, participants were asked to complete a questionnaire about their experience. A 1-week period (washout) was scheduled between the treatment conditions. After the completion of both conditions (electronic and paper), all participants were asked to complete a short comparison questionnaire.
Sample graph correlating activity level with level of pain.
Data sessions (session is defined as one completed diary entry) were transmitted by modem for the electronic condition. For the paper condition, data were gathered on hard-copy forms and data entered centrally. Data from incomplete sessions or duplicate sessions within a 12-h period were not included for analyses. When multiple sessions existed in a 12-h period, the last session was kept unless it was incomplete. The number of pain descriptors was the sum of the characteristics (throbbing, stabbing, aching, burning, pricking, pulling, shooting, numbing, dull) that the participant endorsed. Scores for level of pain and interference with activities ranged from 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes), and were recorded to the nearest 1/10 for the electronic diary data, and to the highest whole number for the paper data. An average score for each variable was computed for each participant.
Analyses were run using SAS version 9.1. For each variable, mean, standard deviation, and range were computed and simple averages were obtained for each participant and for the variables in the electronic and paper conditions. For every variable, difference scores were computed for each participant (difference = electronic − paper). A paired t-test was used to test the null hypothesis that the differences were nonsignificant. A two-sample t-test was used to determine whether the order that the trials were administered mattered.
Forty-two patients with chronic pain were recruited for this study. Of these, complete data were obtained from 36 patients. Demographic information of the participants is presented in Table 1. The subjects averaged 48 years of age, were predominantly female (69%), Caucasian (82%), and had pain for an average of over 8 years. Evaluation of electronic data collection was completed by 40 participants, evaluation of paper data collection was completed by 42 participants, and 39 participants completed the comparison of electronic and paper collection. The analysis of the final data set consisted of 36 participants who completed all aspects of the study. Data were collected for 461 electronic sessions from 40 participants. Data were deleted due to incomplete sessions (six sessions) or duplicate sessions within a 12-h period (58 sessions), leaving 397 sessions for analysis. Data were collected for 583 sessions from 42 participants in the paper diary condition; no sessions were deleted as all data were complete, but it was impossible to determine when the paper diaries were actually completed. Patients reported similar results on both paper and electronic measures on the nature of pain, pain interference, mood, and helpfulness of medications. Statistics summarizing the evaluation and usability of the paper vs electronic diary are found in Table 2.
↵‡ 0 = no pain, 10 = pain as bas as you can imagine.
Patients reported no difference in ease of use between the two conditions; however, when using the electronic diary, patients reported that they found it easier to record data (P < 0.0001) and were more likely to continue using it if it were provided (P < 0.05). Table 3 shows survey variable differences between paper and electronic tracking with respect to pain management. An important finding was that patients using the electronic diary reported that a health care provider suggested change in medication (P < 0.05). One trend requiring further investigation is that electronic diary users reported more frequently that they adjusted or their physician suggested a change to an aspect of their life (i.e., exercise or stress reduction). Finally, participants completed a comparison evaluation after each participant received Condition A and Condition B. Participants reported that the electronic diary was more convenient, saved time and was easier to return data. While they did not report that either format made it easier to communicate with their doctor or manage their pain, they did report that the electronic diary made it easier to understand their symptoms. As reported in previous studies, participants preferred electronic tracking over paper.
Of the 36 participants, 19 used the electronic diary first and 17 used the paper diary first. We looked at 71 variables (average value and difference) to determine if the first mode mattered. There were three significant differences (which we would except with an alpha level of 0.05): patients were more likely to report aching pain by the electronic diary than by the paper diary if they got the electronic device first (P = 0.04), they were more likely to report throbbing pain if they got the paper diary first (P = 0.002), and they were more likely to report being irritable or angry on the electronic diary compared with the paper diary if they got the paper diary first (P = 0.05). It is hard to know if these were spurious findings.
We expected to encounter difficulties with users not familiar with PDA technology. Some users had initial questions about password access during the first or second day of entry, but after successfully using the diary once, had relatively few issues. Two types of technical difficulties were encountered during the study. One technological obstacle of this study was data transmission. Participant data were transmitted via telephone modem on a daily or several times per week basis. Dropped transmission occurred as a result of incoming phone calls, inconvenience for user to plug in the modem, and slow transmission of data. As a back-up, data were stored on the device and transmitted at the end of 2 weeks when the device was returned. To reduce loss of data, we monitored daily which participants had and had not transferred data, so we could proactively determine if they were having trouble with transmission. The second obstacle was related to battery life and has since been resolved by technological advancements in the PDA market. In our pilot study, if the PDA did not remain charged and the battery died, the data would essentially be lost. To avoid this, we made significant effort in the instructions and in follow-up calls to remind participants to charge the battery.
It is important to note that although all participants were able to access the Internet to complete evaluations and view data graphs, it is likely that not all potential users will have web access. As a result, this feature of the program has been modified such that graphing and evaluation activities can be accessed through the mobile device.
The results of this study are in agreement with past investigations that patients tend to prefer electronic over paper monitoring in tracking their pain, mood, activity interference, and medication use. On follow-up interview, patients felt that electronic diaries were more accurate and efficient, that they improved data quality, and patients were comfortable using them. An intriguing finding was that a higher percentage of patients thought that the use of an electronic diary improved their understanding of their condition, and positively influenced their treatment. With the documented preference of electronic tracking, the relative availability of handheld technology, and the increased desire for its use in physician and patient populations, several important questions have been raised. We do not know, for instance, whether these results are a product of using something new and different compared with paper measures, or whether the patients really found that electronic tracking improved their understanding and management of their symptoms. We are also uncertain of how the providers responded to the use of electronic tracking. Did the physicians welcome the information and was it in anyway helpful in patient management? Another question raised as a part of the study is whether clinic-based data collection would be as useful and comparable to more-frequent home-based collection. Some have argued persuasively on the intrinsic benefits of momentary data collection (see Stone and Broderick in this supplement). However, would integration of electronic tracking in the clinic setting be as useful and efficient as home-based monitoring over time, and which method would allow for ready integration into a medical care setting, particularly in light of the use of electronic medical records and concern over security of there records?
Providers are increasingly faced with the informed patient who attends a visit armed with materials from the Internet or primed by television ads on ways to improve their care. Enabling patients to understand patterns of pain and factors that exacerbate or provide relief have tremendous potential for allowing patients to modify behavior between medical care visits. Importantly, targeting factors that may exacerbate pain can potentially reduce service utilization. In the modern era of the informed patient, there is increasingly interest in having access to such information and electronic tracking is an obvious avenue for accomplishing this.
Physician use of PDAs is also on the rise as providers with less time attempt to keep up with the growing amounts of (often changing) information provided in medical journals, formularies, and guidelines. As a result, medical professionals are becoming more familiar with the PDA as a clinical tool, and may be more inclined to review real-time patient information prior to a clinic visit. Enabling physicians to quickly identify historical trends in symptom reporting and changes in pain with mood or activity fluctuations has tremendous potential to provide an accurate summary of information during a busy clinic with reduced patient face time. Familiarity and comfort with this form of electronic technology combined with demonstrated benefits of electronic data capture, real-time reporting, and historical charting of data can potentially improve chronic pain management and improve patient satisfaction with care. Importantly, such data could easily be shared with other providers within the pain management team.
One concern about electronic data captured in a clinic setting is whether information is as reliable as daily home-based reporting. Home-based reporting has advantages in that it provides for more frequent momentary reporting of pain symptoms during routine daily activities. Electronic data capture by patients in their home also has limitations such as losing charge on the device, difficulties encountered with transmission of data, using the device for other unintended activities, or, most importantly, not completing regular entries. Interestingly, electronic monitoring contributed to more incomplete data in this study than in the paper condition. In future studies, data should be stored in nonvolatile memory on a compact flash card to avoid lose of data. An important question for future research is whether regular clinic-based data collection (for example, monthly visits to a pain clinic) over a long period of time (years) is comparable to the potentially more in-depth information captured through daily diary recordings at home. Clinic-based data collection can be convenient, and could be an equally viable source of longitudinal tracking of pain status, although further comparison with home-based data collection is needed.
Finally, having evidence that a new technology is functional and well-liked is an important first step. However, there is a serious research question concerning efficacy vs effectiveness. As a first step, it is important to understand if an intervention, such as tracking pain electronically, has an impact on patient care in a clinic setting. Beyond this, however, it is critical to understand if the potential audience for such technology (chronic pain patients and their treating physicians) would adopt this technology in everyday clinical practice. For example, in our pilot study, 22 patients (61%) agreed that they would continue to use the electronic diary if it were provided; however, they were not willing to purchase the software. In fact, the majority of respondents did not own a PDA and did not have plans to purchase one. Although these results were from pilot data, this informs future research and is part of a larger study now underway.
There are a number of limitations of this study that deserve mention. First, only a limited number of subjects participated in this study and they were followed for a relatively short period of time. As a result, there may be reduced effect differences compared with a longer trial. Second, this prototype developed under a Phase I Small Business Innovative Research (SBIR) grant was designed as a preliminary feasibility study with primary focus on acceptability and usability of the different measures. A longitudinal study (funded by a Phase II SBIR grant) is currently ongoing that focuses on perceived patient and provider differences in treatment based on feedback of electronic historical data. Chart use between patient and provider will be a key component of this study. More information will also be available on how providers and patients use the output provided by the electronic diaries in changing treatment practice. Third, because all participants in this study were asked to use both the electronic and paper diaries, which they may not have typically been asked to keep, it is hard to determine whether responses were influenced by the nonspecific effects of attention. For this study design, participants acted as their own controls, but it is possible that simply being part of the study increased their compliance or influenced their pain reporting.
Despite these limitations, these survey data offer some intriguing suggestions of how electronic data could be valuable in a clinic setting. It goes beyond simply reporting that electronic diary tracking is preferred over paper and provides better quality data, but suggests that electronic tracking holds promise for improving physician and patient communication regarding pain management.
Chronic pain management is a difficult condition to treat requiring long-term coordinated care. The evolution of electronically monitored pain status has broad implications for health care, policy, and improvement in quality of care for chronic pain sufferers and their treating physicians. Whether the use of electronic tracking is able to modify physician or patient behavior relating to medication use, lifestyle, or behavior change is a critical question. While our preliminary results on the comparison of paper and electronic diary tracking cannot answer this and other questions, the results are suggestive of a trend that requires further investigation. A longitudinal, randomized, controlled trial with an electronic diary and paper diary arm currently underway will hopefully address these issues. The study also incorporates a home-based component, which will allow us to investigate whether home-based (frequent) data are comparable to clinic-collected (infrequent) data. Both forms of data collection include a charting component enabling physicians and patients to view historical data concerning factors associated with pain such as medication use and pain location. An important outcome of the follow-up study is to determine if understanding their symptoms enable patients to regain control over pain management by modifying activities to improve pain status. Second, we will investigate whether charting pain over time allows physicians to neutralize the impact of a shortened clinic visit by more quickly and easily identifying patterns in pain and activity or medications and relief. Ease of access to this information could reduce the burden associated with managing chronic pain. Importantly, quality pain tracking could potentially move physician focus toward patient symptom management rather than simply treatment compliance. These findings will have important implications for future integration of technology and medicine. Continuing research in this area will inform how an ultimately helpful technology can be integrated into an existing paradigm to improve patient perceptions, physician management, and clinic efficiency.
This work was supported by a grant from the National Institutes of Health, National Institute of Dental and Craniofacial Research (R01 DE014797). The authors would like to thank Randi Triant, Brian Schuth, Maile Moore, and Margaret Daly for their contribution to this study. This project is supported by Grant No. DE014797 from the National Institute of Dental and Craniofacial Research, NIH.
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