title: Self-medication of a single headache episode with ketoprofen, ibuprofen or placebo, home-monitored with an electronic patient diary. 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 [Real time collection of pain profile in treatment with ibuprofen]. Using Interaction Graphs for Analysing the Therapy Process [Validation of electronic by conventional pain diaries]. Characterization and consequences of pain variability in individuals with fibromyalgia. Brief cognitive-behavioral therapy for temporomandibular disorder pain: Effects on daily electronic outcome and process measures Two replicate randomized, double-blind, placebo-controlled trials of the time to onset of pain relief in the acute treatment of migraine with a fast-disintegrating/rapid-release formulation of sumatriptan tablets. Intensive momentary reporting of pain with an electronic diary: reactivity, compliance, and patient satisfaction Premonitory symptoms in migraine Sequential daily relations of sleep, pain intensity, and attention to pain among women with fibromyalgia
abstract: 1 . The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory ( NSAID ) analgesics , using an electronic patient diary . Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic tension-type headache , using a double-blind , r and omized , parallel group design . 2 . A total of 166 patients with headache compatible with episodic tension-type headache and no refractory headaches or contraindications to NSAIDs  were contacted by advertisements and selected by question naires . Patients performed the study at home , using an electronic diary for headache assessment , with a form to allow comments and corrections . Visual analogue scales ( VAS 10 cm ) of headache severity , five-item headache relief rating ( HRR ) scales , and time of intake of ' escape ' analgesics were scored regularly , for 4 h following intake of trial medication . 3 . VAS-scores ( n = 1407 ) and HRRs ( n = 452 ) were returned by 159 patients . Of these scores , 1.5 % were inadvertently omitted from the electronic diary or modified on the comment forms . 4 . Headache ( VAS and HRR ) improved more with all three NSAIDs than with placebo , although the effect of ibuprofen was significant for HRR only . After 2 and 4 h respectively , the reduction in VAS-ratios was 17 and 19 % with placebo , 18 and 53 % with ibuprofen 200 mg , 41 and 61 % with ketoprofen 25 mg , and 47 and 59 % with ketoprofen 50 mg . After 4 h , headache improved strongly ( highest HRR ) in 18 % of patients on placebo , 39 % on ibuprofen 200 mg , 62 % on ketoprofen 25 mg , and 55 % on ketoprofen 50 mg . Headache disappeared completely ( VAS-score = 0 ) in one patient ( 3 % ) with placebo ( after 180 min ) , 10 % with ibuprofen 200 mg ( average 211 min ) , 18 % with ketoprofen 25 mg ( 159 min ) , and 28 % with ketoprofen 50 mg ( 146 min ) . 5 . The effects of ketoprofen 50 mg were more pronounced than those of ibuprofen 200 mg , which seemed to start later . Ketoprofen 25 mg and 50 mg were very similar , suggesting a maximal effect of the lower dose . Mild to moderate adverse events were reported by 9 % of the patients , half of which occurred with ketoprofen 50 mg . Treatment of headache with ketoprofen can start with 25 mg , and possibly less . 6 . Although a direct comparative study would be necessary to determine the relative benefits of the novel electronic patient diaries over traditional paper- and -pencil methods , this study has shown the usefulness of this newer technique to detect differences in efficacy between low doses of analgesics under ambulant conditions , with very limited loss of data . Electronic patient diaries appear to be an important new attribute for the efficacy assessment of self-medicated drugs 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 In an open three-center pilot study , 17 patients suffering from chronic persistent pain syndrome , due to osteoarthritis of the hip and knee or spondylarthrosis , were treated orally with 1800 - 2400 mg Ibuprofen per day for 3 weeks . The chronic pain syndrome and joint status were assessed by the physician at the beginning , and after 7 , 14 and 21 days . Self- assessment s were made by the patients six times daily during the full study period by means of battery-driven electronic diaries ( E.D. ) . The data entered by the patients were stored in the E.D. and after online transfer , processed and evaluated in a PC using appropriate software programs . E.D. were returned by 16 of 17 patients for evaluation . The technical functioning of the instrument was perfect ; its use was accepted by patients and physicians . The closely-meshed real-time recording of pain course and other subjective data , such as adverse events or medication , etc . , enables the physician to calculate more exactly and reliably improvement rates , as well as to carry out prognostic trend analyses and individual benefit-risk-ratio estimates . By comparing different kinds of data , each entered at the same time , plausibility checks are possible . The procedure presented here is considered to be a new valuable tool for review ing subjective data from clinical drug trials Background : Therapy processes are complex dynamical systems where several variables are constantly interacting with each other . In general , the underlying mechanisms are difficult to assess . Our approach is to identify the dependency structure of relevant variables within the therapy process using interaction graphs . These are instruments for multivariate time series which are based on the analysis of partial spectral coherences . We used interaction graphs in order to investigate the therapy process of a multimodal therapy concept for fibromyalgia patients . Our main hypothesis was that self-efficacy plays a central role in the therapy process . Methods : Patients kept an electronic diary for 13 weeks .  Pain intensity , depression , sleep quality , anxiety and self-efficacy were assessed via visual analogue scales . The result ing multivariate time series were aggregated over individuals , and partial spectral coherences between each pair of the variables were calculated . From the partial coherences , interaction graphs were plotted . Results : Within the result ing graphical model , self-efficacy was strongly related to pain intensity , depression and sleep quality . All other relations were substantially weaker . There was no direct relationship between pain intensity and sleep quality . Conclusions : The relations between two variables within the therapy process are mainly induced by self-efficacy . Interaction graphs can be used to pool time series data of several patients and thus to assess the common underlying dependency structure of a group of patients . The graphical representation is easily comprehensible and allows to distinguish between direct and indirect relationships 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 OBJECTIVE A growing body of evidence suggests that real-time electronic assessment s of pain are preferable to traditional paper- and -pencil measures . We used electronic assessment data derived from a study of patients with fibromyalgia ( FM ) to examine variability of pain over time and to investigate the implication s of pain fluctuation in the context of a clinical trial . METHODS The study group comprised 125 patients with FM who were enrolled in a r and omized , placebo-controlled trial of milnacipran .  Pain intensity levels  were captured in real time by participants using electronic diaries .  Variability in pain was assessed as the st and ard deviation of pain entries over time ( pain variability index [ PVI ] ) . RESULTS Substantial between-subject differences in pain variability were observed ( mean + /- SD PVI 1.61 + /- 0.656 [ range 0.27 - 4.05 ] ) . The fluctuation in pain report was constant over time within individuals ( r = 0.664 , P < 0.001 ) . Individuals with greater variability were more likely to be classified as responders in a drug trial ( odds ratio 6.14 , P = 0.006 ) ; however , this association was primarily attributable to a greater change in pain scores in individuals receiving placebo ( r = 0.460 , P = 0.02 ) rather than active drug ( r = 0.09 , P > 0.10 ) . CONCLUSION Among individuals with FM , there were large between-subject differences in real-time pain reports . Pain variability was relatively constant over time within individuals . Perhaps the most important finding is that individuals with larger pain fluctuations were more likely to respond to placebo . It is not clear whether these findings are applicable only to patients with FM or whether they may also be seen in patients with other chronic pain conditions & NA ; We used patient daily electronic ratings of outcome ( activity interference , pain intensity , jaw use limitations , negative mood ) and process ( pain‐related beliefs , catastrophizing , and coping ) variables to evaluate a brief cognitive‐behavioral ( CB ) treatment for chronic temporom and ibular disorder ( TMD ) pain . TMD clinic patients ( N=158 ) were assigned r and omly to four biweekly sessions of either CB pain management training ( PMT ) or an education/attention control condition [ self‐care management ( SCM ) ] and were asked to complete electronic interviews three times daily for the 8‐week treatment . We analyzed diary data from 126 participants who completed > 50 % of requested interviews for > 6 weeks . Multilevel regression analyses indicated no statistically significant difference between the study groups in rate of within‐subject change over time on the daily outcome measures , but consistently greater within‐subject improvement in the PMT group on the daily process measures . Significantly ( P<0.05 ) greater proportions of PMT than of SCM patients showed clinical ly important ( > 50 % ) improvement from weeks 1 to 8 in daily activity interference and jaw use limitations . This study is novel in its application of electronic diary methods for assessing outcome and process variables in a chronic pain treatment trial , and supports the feasibility and utility of such methods . The brief CB treatment was efficacious in decreasing catastrophizing and increasing perceived control over pain , and in improving activity interference and jaw use limitations for a subgroup of patients . Longer‐term follow‐ups are ongoing to determine if there is an impact on outcomes over time BACKGROUND The gastric stasis that commonly accompanies migraine headache may impair absorption of conventional oral tablets in the stomach . A fast-disintegrating/rapid-release formulation of sumatriptan has been developed to enhance tablet disintegration and drug dispersion and potentially improve absorption . OBJECTIVE Two studies were conducted comparing the time to onset of relief from moderate or severe migraine pain with the fast-disintegrating/rapid-release formulation of sumatriptan tablets 50 and 100 mg and placebo . METHODS These were 2 identically design ed r and omized , double-blind , parallel-group studies . Sumatriptan 50 or 100 mg or placebo was taken on an outpatient basis to treat a single moderate or severe migraine attack . Using a personal digital assistant , patients recorded the time of dosing and the time at which pain severity reached none or mild ( ie , pain relief ) or none ( ie , pain free ) in real time so that the time to onset of relief could be measured as a continuous variable . Onset of relief was defined as the earliest time point at which a statistically significant difference in pain relief compared with placebo was achieved and maintained through 2 hours after dosing . Before dosing and at pre-determined time points after dosing , patients also provided an assessment of migraine pain as none , mild , moderate , or severe . At a clinic visit within 1 week after treatment of the migraine attack , patients were queried about adverse events . For each adverse event , investigators recorded whether study medication was considered the cause . Data analyses were undertaken for each study individually and , in post hoc analyses of the primary and key secondary end points , on pooled data from both studies . RESULTS The 2 studies comprised 2696 patients : 902 received sumatriptan 50 mg , 902 received sumatriptan 100 mg , and 892 received placebo . Patients ' mean age ranged from 40.2 to 40.8 years across treatment groups , and most patients were female ( 83%-87 % ) and white ( 92%-93 % ) . In the analysis of pooled data , sumatriptan tablets provided significantly more effective pain relief compared with placebo as early as 20 minutes after dosing with the 100-mg dose and as early as 30 minutes after dosing with the 50-mg dose ( P < or = 0.05 ) . Similar results were observed for the individual studies : in study 1 , sumatriptan tablets were significantly more effective than placebo at 25 minutes with the 100-mg dose and at 50 minutes with the 50-mg dose ; in study 2 , sumatriptan tablets were significantly more effective than placebo at 17 minutes for the 100-mg dose and at 30 minutes for the 50-mg dose ( P < or = 0.05 ) . In the pooled data , the cumulative percentages of patients with pain relief by 2 hours after dosing were 72 % for the 100-mg dose and 67 % for the 50-mg dose , compared with 42 % for placebo ( P < or = 0.001 , both sumatriptan doses vs placebo ) . The cumulative percentages of patients with a pain-free response by 2 hours were 47 % for the 100-mg dose , 40 % for the 50-mg dose , and 15 % for placebo ( P < or = 0.001 , both sumatriptan doses vs placebo ) . In the individual studies , significantly more patients receiving either sumatriptan dose were migraine free 2 hours after dosing and had sustained pain relief and a sustained pain-free response over 24 hours compared with placebo ( P < or = 0.001 , both sumatriptan doses vs placebo ) . The only drug-related adverse events reported in > 2 % of patients in any treatment group in either study were nausea ( both studies : 3 % sumatriptan 100 mg , 2 % sumatriptan 50 mg , 1 % placebo ) and paresthesia ( study 1 : < 1 % sumatriptan 100 mg , < 1 % sumatriptan 50 mg , 0 % placebo ; study 2 : 3 % sumatriptan 100 mg , 1 % sumatriptan 50 mg , < 1 % placebo ) . CONCLUSIONS In these studies , sumatriptan tablets in a fast-disintegrating/rapid-release formulation were effective for the acute treatment of moderate to severe migraine pain , were generally well tolerated , and achieved an onset of pain relief as early as 20 minutes for 100 mg and as early as 30 minutes for 50 mg & 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 Background : Migraine is frequently associated with nonheadache symptoms before , during , and after the headache . Premonitory symptoms occurring before the attack have not been rigorously studied . Should these symptoms accurately predict headache , there are considerable implication s for the pathophysiology and management of migraine . Methods : Electronic diaries were used in a 3-month multicenter study to record nonheadache symptoms before , during , and after migraine . The authors recruited subjects who reported nonheadache symptoms in at least two of three attacks that they believed predicted headache . Symptoms were entered in the diaries by patient initiation and through prompted entries at r and om times daily . Entries could not be altered retrospectively . Data recorded included nonheadache symptoms occurring during all three phases of the migraine , prediction of the attack from premonitory symptoms , general state of health , and action taken to prevent the headache . Results : One hundred twenty patients were recruited : 97 provided usable data . Patients correctly predicted migraine headaches from 72 % of diary entries with premonitory symptoms . A range of cognitive and physical symptoms was reported at a similar rate through all three phases of the migraine . The most common premonitory symptoms were feeling tired and weary ( 72 % of attacks with warning features ) , having difficulty concentrating ( 51 % ) , and a stiff neck ( 50 % ) . Subjects who functioned poorly in the premonitory phase were the most likely to correctly predict headache . Conclusions : Using an electronic diary system , the authors show that migraineurs who report premonitory symptoms can accurately predict the full-blown headache & NA ; Fifty women with fibromyalgia syndrome ( FS ) recorded their sleep quality , pain intensity , and attention to pain for 30 days , using palm‐top computers programmed as electronic interviewers . They described their previous night 's sleep quality within one‐half hour of awakening each day , and at r and omly selected times in the morning , afternoon , and evening rated their present pain in 14 regions and attention to pain during the last 30 min . We analyzed the 30‐day aggregates cross‐sectionally at the across‐persons level and the pooled data set of 1500 person‐days at the within‐persons level after adjusting for between‐persons variation and autocorrelation . Poorer sleepers tended to report significantly more pain . A night of poorer sleep was followed by a significantly more painful day , and a more painful day was followed by a night of poorer sleep . Pain attention and sleep were unrelated at the across‐persons level of analysis . But there was a significant bi‐directional within‐person association between pain attention and sleep quality that was not explained by changes in pain intensity
target: Compliance was generally high , and positively associated with shorter diaries , age , having a user 's manual , financial compensation and using an alarm .
background: 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 .