Zeitschrift für Rheumatologie
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Important physiological parameters such as blood pressure, ECG and others are measured today on a continuous basis or at fixed intervals and are documented together with the date and the time. Individual results and subjective data are ascertained through questioning the patient, observation or patient's self-assessment and are documented with paper and pencil, without having any certainty of the exact time of ascertainment or that such is comprehensible. Battery-operated microcomputers have been developed in the form of electronic diaries (E. ⋯ The percentage change in the pain course, benefit risk considerations, prognoses with the aid of sequential analyses and plausibility criteria can be calculated from the data. The advantages of this new instrument are its simple handling and reliable functioning. Its disadvantage is that it lacks the possibility to allow free-style entries.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
[Real time collection of pain profile in treatment with ibuprofen].
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-assessments were made by the patients six times daily during the full study period by means of battery-driven electronic diaries (E. ⋯ 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 reviewing subjective data from clinical drug trials.
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Randomized Controlled Trial Comparative Study Clinical Trial
[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. ⋯ 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.