A randomized trial of electronic versus paper pain diaries in children: impact on compliance, accuracy, and acceptability Intensive momentary reporting of pain with an electronic diary: reactivity, compliance, and patient satisfaction Patient compliance with paper and electronic diaries. Electronic diary assessment of pain-related variables: is reactivity a problem? Pain Assessment in Patients With Fibromyalgia Syndrome: A Consideration of Methods for Clinical Trials Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study. Electronic diaries as a tool to improve pain management: is there any evidence? [Validation of electronic by conventional pain diaries]. Compliance with inhaled medications: The relationship between diary and electronic monitor A Randomized Trial Evaluating Prosaptide™ for HIV-Associated Sensory Neuropathies: Use of an Electronic Diary to Record Neuropathic Pain Peak flow diaries in childhood asthma are unreliable Paper or plastic? Data equivalence in paper and electronic diaries.
& NA ; Electronic diary assessment of pain and disability has become increasingly popular in adult chronic pain research but use of this methodology with children has received limited attention . The aim of this study was to compare two formats of a prospect i ve daily diary ( h and held computer = e‐diary ; paper diary = p‐diary ) on children 's compliance , accuracy , and acceptability ratings . Sixty children , ages 8–16 ( M=12.3 ) with headaches or juvenile idiopathic arthritis , were r and omized to receive either  e‐diaries administered via home visits ( n=30 ) or  p‐diaries  ( n=30 ) h and ed out during clinic visits for return by mail . Results demonstrated significant mean differences in diary entries completed between groups , with children with e‐diaries completing more days ( M=6.6 ) compared to children with p‐diaries ( M=3.8 ) , P<0.001 . Diaries returned by children in the p‐diary group contained significantly more errors and omissions compared to diaries returned by children in the e‐diary group ( which contained none ) , P<0.001 . Children rated both diary formats as highly acceptable and easy to use . A significant gender × diary format interaction ( P<0.01 ) was found for compliance where boys demonstrated greater compliance with the e‐diary format . Findings demonstrated that the e‐diary was feasible to use with children and showed significantly greater compliance and accuracy in diary recording compared to traditional paper diaries in a population of children with recurrent pain & NA ; Patient self‐reports are the primary method for capturing the experience of pain , and diaries are often used to collect patient self‐reports . This study was design ed to determine if momentary monitoring of pain with an electronic diary affected pain levels over time , if it affected weekly recall of pain , and if daily sampling density affected compliance rates and patients ’ reactions to the study . Ninety‐one patients with chronic pain were r and omized into four groups with differing levels of momentary monitoring over 2 weeks . Little support was found for reactivity defined as temporal shifts in pain over the study or as changes in recalled weekly pain due to momentary monitoring . Compliance with the electronic diary protocol was 94 % or better , and was not related to sampling density . Patients reported little difficulty with the diary procedures and were not unduly burdened by the protocol Paper diaries are commonly used in health care and clinical research to assess patient experiences . There is concern that patients do not comply with diary protocol s , possibly invalidating the benefit of diary data . Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features .  Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries . Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days . Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries ( defined by comparing the written times and the electronically-recorded times of diary use ) . Actual compliance was recorded by the electronic diary . Participants su bmi tted diary cards corresponding to 90 % of assigned times ( + /-15 min ) . However , electronic records indicated that actual compliance was only 11 % , indicating a high level of faked compliance . On 32 % of all study days the paper diary binder was not opened , yet reported compliance for these days exceeded 90 % . For the electronic diary , the actual compliance rate was 94 % . In summary , participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features . The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information UNLABELLED Reactive measures ( measures that change the phenomenon assessed ) cause problems in interpreting any changes observed . This study examined whether electronic daily diary measures of pain , activity interference , mood , and pain beliefs were reactive in terms of both observable data and patient-reported effects . Patients with chronic temporom and ibular disorder pain ( N = 71 , 86 % female ) completed electronic diaries 3 times daily for approximately 2 weeks and subsequently reported perceived effects on symptom-related variables . Seventy-three percent of patients reported that the assessment affected their pain , whereas 51 % , 45 % , and 39 % thought that it affected their daily activities , mood , and beliefs , respectively . In contrast , there was little objective evidence of reactivity as observed in the electronic diary ratings ; changes over 14 days were small ( eg , predicted changes on 0 to 10 scales : positive mood , .1 ; pain , -.3 ; perceived control , -.5 ) and not statistically significant . Subjective reactivity was generally not significantly related to objective reactivity . The data suggest that patients view daily assessment as having positive and negative effects on pain-related variables , but pain-related measures do not show reactive effects . PERSPECTIVE Electronic daily diary assessment methods hold the potential to increase knowledge concerning patients ' experiences with pain and sequential relations between pain-related variables , but only if the measurement process is nonreactive . This study provides evidence that electronic diary assessment of pain-related variables is nonreactive Objective : This study was design ed to compare 3 commonly used method ologies for assessing clinical pain during trials involving patients diagnosed with fibromyalgia syndrome . Baseline characteristics , characteristics over time , and compliance were evaluated for each of the methods . Methods : Fourteen patients diagnosed with fibromyalgia syndrome were asked to monitor their symptoms of pain using 3 different strategies over a 12-week period : 1 ) real-time pain reports were collected on an electronic diary using r and omly-scheduled audible prompts ; 2 ) end-of-week reports asked patients to rate their mean pain over the past week on the electronic diary ; and 3 ) monthly in-clinic reports asked patients to rate their mean pain for the week using a traditional paper and pencil diary . Results : Significantly different baseline values were obtained for the 3 methods . Paper and pencil produced the highest values , and real-time pain reports produced the lowest baseline values . Pain ratings were more likely to reflect decreases in the 2 methods relying on recall than the real-time strategy . The average adherence with pain monitoring using the electronic diary was 85 % , which was superior to the adherence for the recall measures completed during the clinic visits . Conclusion : Pain assessment methods relying on recall might contribute to an apparent improvement in clinical trials in the absence of an intervention ; such an effect has been considered a “ placebo response . ” Future clinical trials might consider using a real-time approach to pain assessment  , which in this study appeared to mitigate against seeing improvement in the absence of an intervention and demonstrated higher levels of patient adherence BACKGROUND Daily diaries are a useful way of measuring fluctuations in pain-related symptoms . However , traditional diaries do not assure the gathering of data in real time , not solving the problem of retrospective assessment . Ecological momentary assessment ( EMA ) by means of electronic diaries helps to improve repeated assessment . However , it is important to test its feasibility in specific population s in order to reach a wider number of people who could benefit from these procedures . METHODS The present study compares the compliance and acceptability of an electronic diary running on a smartphone using a crossover design for a sample with a specific pain condition , fibromyalgia and low familiarity with technology . Forty-seven participants were r and omly assigned to one of two conditions : ( 1 ) paper diary - smartphone diary and ( 2 ) smartphone diary - paper diary , using each assessment method for 1 week . RESULTS The findings of this study showed that the smartphone diary made it possible to gather more accurate and complete ratings . Besides , this method was well accepted by a sample of patients with fibromyalgia referred by a public hospital , with an important proportion of participants with low level of education and low familiarity with technology . CONCLUSIONS The findings of this study support the use of smartphones for EMA even in specific population s with a specific pain condition , fibromyalgia and with low familiarity with technology . These methods could help clinicians and research ers to gather more accurate ratings of relevant pain-related variables even in population s with low familiarity with technology 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 design ed 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 , r and omized , 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 implication s for health care , policy , and improvement in quality of care for chronic pain sufferers in the future A new type of electronic pain diary was vali date d in an open , r and omized , crossover study . The main target variables were the comparison of the correctly realized pain assessment entries as well as the recording of the number of adverse events . Selected for the study were 20 patients , who were either hospitalized , partially-hospitalized or treated on an out-patient basis , with painful spondylogenic spinal syndrome or osteoarthritis of the trunk-proximal large joints . The patients were r and omly-assigned to the two groups . The first group initially received the conventional diary and thereafter the electronic diary ; the sequence was reversed for the second group . The drug therapy consisted of the NSAID , Ibuprofen , at an individually-adjusted dosage . Additional therapeutic measures were carried out by all the patients . The electronic pain diary proved to be equivalent to the conventional diary with regard to adherence of the pain assessment entry times . At a defined equivalence range of + /- 20 % , the statistical comparison showed that the limits were never exceeded . The equivalence test of And erson-Hauck showed a significance level of p less than 0.0001 . The minimum equivalence range was + /- 2 % . It therefore follows , that the conventional method of data recording can indeed be fully replaced by the electronic method . Comparing the individual data of the 16 patients , from whom entries with both the electronic as well as the conventional pain diaries were su bmi tted , a clear tendency for increased entries on adverse events in the electronic diary ( C.D. 6.4 + /- 10.5/E.D. 36.4 + /- 44.1 ) was demonstrated . No significant difference , however , was shown for the number of patients making data entries on adverse events in the electronic pain diary compared to those patients , who made their entries on adverse events in the conventional diary . According to the data from the physicians and patients , the  Ibuprofen treatment results in an improvement in 90%/75 % of cases , respectively . Likewise , the functional impairment of the affected joints as well as the swelling decreased markedly . The advantages of the electronic data recording system , i.e. closely-meshed controls can be carried out , transcriptional errors are minimized , data can be processed on-line , no possibility to subsequently change an entry , st and in contrast to the feature that there is no possibility to make free-style entries . The employment of the electronic system in the recording of individual data and subjective data represents a substantial improvement with regard to the quantity and quality of the data Self-report is a frequently-used method of assessing compliance with prescribed medications in patients with chronic illnesses . Most research ers agree , however , that self-report misrepresents patient adherence to regimen prescription . In this r and omized , controlled study evaluating inhaler medication compliance , diary data was compared to electronic monitoring in 55 adults with asthma . Subjects r and omized to the treatment group received a six-week self-management program . An electronic monitor , the MDI Chronolog , was used in this study to assess inhaler use . The MDI Chronolog records the date and time of each inhaled activation . The self-report measure used was a daily asthma diary . Subjects were asked to use their inhaled medications as usual and record the date and time they administered their medication over a one-week period . Moderate correlations ( rs=.55 , Mdnd=95.8 , Mdnc=91.6 ) were found when comparing the number of administrations calculated using the MDI Chronolog to the number of administrations reported in the subject ’s diary . When the dosing interval was examined , however , the correlation was weaker ( rs=.44 , Mdndiary=92.8 , Mdnchronolog=37.5 ) . In each case , self-reported compliance was higher than monitored adherence Objectives To examine the efficacy and safety of Prosaptide ™ ( PRO ) for the treatment of painful HIV-associated sensory neuropathies ( HIV-SN ) . Design A r and omized , double-blind , placebo-controlled , multicenter study in participants with sensory neuropathy .  Pain modulating therapy was discontinued prior to baseline . Participants were stratified by sural sensory nerve action potential ( SNAP ) amplitude . Participants were trained to use an electronic diary ( ED ) to record pain . Setting Peripheral neuropathies are common complications of HIV infection . The pathogenesis is unknown and currently treatments are restricted to symptomatic measures . We examined PRO against placebo ( PBO ) for treatment of painful HIV-SN and performed a post-hoc evaluation of an electronic diary ( ED ) to record HIV-associated neuropathic pain . Participants Eligible participants included adults with neurologist-confirmed painful HIV-SN . Interventions 2 , 4 , 8 , or 16 mg/d PRO or PBO administered via subcutaneous ( SC ) injection for six weeks . Neurotoxic antiretroviral drug usage was held constant . Outcome Measures Changes from baseline in the weekly average of evaluable daily r and om prompts measuring pain using the Gracely pain scale and adverse events . Results 237 participants were r and omized . The study was stopped after a planned futility analysis . There were no between-group differences in the frequency of adverse events or laboratory toxicities . The 6-week mean ( sd ) Gracely pain scale changes were −0.12 ( 0.23 ) , −0.24 ( 0.35 ) , −0.15 ( 0.32 ) , −0.18 ( 0.34 ) , and −0.18 ( 0.32 ) for the 2 , 4 , 8 , 16 mg , and PBO arms respectively . A similar variability of pain changes recorded using the ED were noted compared to previous trials that used paper collection methods . Conclusions 6-week treatment with PRO was safe but not effective at reducing HIV-associated neuropathic pain . Use of an ED to record neuropathic pain is novel in HIV-SN , result ed in reasonable compliance in recording pain data , but did not decrease the variability of pain scores compared to historical paper collection methods . Trial Registration Current Controlled Trials BACKGROUND A study was undertaken to investigate the compliance with and accuracy of peak flow diaries in childhood asthma . METHODS Forty asthmatic children ( 5–16 years ) were asked to perform peak flow measurements twice daily for 4 weeks by means of an electronic peak flow meter and to record values in a written diary . Patients and parents were unaware that the device stored the peak flow values on a microchip . In r and om order , half of the patients were only told that the device allowed for more accurate assessment of peak flow while the other half were told that accurate recording of peak flow was important because the results would be used in guiding adjustments to treatment . Data in the written diary ( reported data ) were compared with those from the electronic diary ( actual data ) . RESULTS In the entire study population the mean ( SD ) actual compliance ( 77.1 (20.5)% ) was much lower than the mean reported compliance ( 95.7 (9.1)% ) ( 95 % CI for difference 12.7 % to 24.4 % ) The percentage of correct peak flow entries decreased from 56 % to < 50 % from the first to the last study week ( p<0.04 ) , mainly as a result of an increase in self-invented peak flow entries . Results were comparable for both groups . For incorrect peak flow entries the mean difference between written and electronically recorded entries ranged from –72 to 34 l/min per patient . CONCLUSIONS Peak flow diaries kept by asthmatic children are unreliable . Electronic peak flow meters should be used if peak flow monitoring is required in children with asthma Concern has been raised about the lack of participant compliance  in diary studies that use paper- and -pencil as opposed to electronic formats . Three studies explored the magnitude of compliance problems and their effects on data quality . Study 1 used r and om signals to elicit diary reports and found close matches to self-reported completion times , matches that could not plausibly have been fabricated . Studies 2 and 3 examined the psychometric and statistical equivalence of data obtained with paper versus electronic formats . With minor exceptions , both methods yielded data that were equivalent psychometrically and in patterns of findings . These results serve to at least partially mollify concern about the validity of paper diary methods
Compliance was generally high , and positively associated with shorter diaries , age , having a user 's manual , financial compensation and using an alarm .
Electronic diaries are increasingly used to assess daily pain in many different forms and population s. This systematic review aims to survey the characteristics of studies using electronic pain diaries and to examine how these characteristics affect compliance .