[Validation of electronic by conventional pain diaries]

A new type of electronic pain diary was validated in an open, randomized, 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 randomly-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 Anderson-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 submitted, 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, stand 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.