Patient diary

The use of wireless computer systems has gain popularity in data collection for clinical trials. They have been used as a substitute for normal paper-based patient diaries (Koop et al. [19]) to increase data quality and shorten the time needed to close the database. They have also been used for mobile interviewing [20] and for bedside data collection [21]. In patient-directed data entry, subjects are given handheld computers to answer the trial s questions (Clarke et al. [22]). 

Obviously, if the clinical mirror approach to bioequivalency testing gains momentum, we may expect to see more quantification of clinical response in bioequivalency studies. In some instances pharmacodynamic parameters that are amenable to precise quantification are easily identified. Thus, if we are working with an antihypertensive drug, measurement of blood pressure using an electronic sphygnomanometer is an obvious option. However, for many drugs there is no simple way to quantify pharmacodynamic response. In some cases we may have to rely, to some extent at least, on patient diaries [41]. Such techniques are open to criticism of subjectivity and imprecision. 

For variant angina, reduction in symptoms and nitroglycerin consumption as documented by a patient diary can assist the interpretation of objective data obtained from ambulatory ECG recordings. Evidence of efficacy includes the reduction of ischemic events, both ST-segment depression and elevation. Additional evidence is a reduced number of attacks of angina requiring hospitalization, and the absence of MI and sudden death. 

The pharmacist should therefore look to reinforce the information already provided to Mrs RP by outlining those parameters being monitored (i.e. tumour marker, symptoms and a CT scan after the third or fourth cycle). It will also be necessary to inform Mrs RP of the need to monitor carefully for side-effects. Often it is useful for patients to be asked to record the side-effects that they suffer from during treatment in a patient diary booklet or similar. 

These methods of measuring compliance continue to be used in clinical trials, although none of them fulhll the criterion of providing an accurate measurement of drug taken. Since they are not, in and of themselves, acceptable measures of compliance, they can only serve to confound the analysis and interpretation of the compliance exposure-response relationships. However, ancillary information from patient diaries, for example, may be helpful in interpreting data collected by other means—such as MEMS and others described above (24). A combination of MEMS and patient diaries may give an unbiased estimate of compliance. 

Noncompliance with prescribed medication regimens is a major problem in pharmacotherapy and results in 300,000 deaths in the United States annually. There are three distinguishing phases to noncompliance (a) acclimatization period, (b) compliance with the decision, and (c) discontinuation. Several methods are used to measure patient compliance to drug therapy. They range from direct questioning and the use of interview instruments, to patient diaries, pill counts, MEMS, drug... 

Patient diary. A record of symptoms and occasionally other measurements maintained by a patient in a therapeutic trial. Sometimes this is regarded as being part of the CRF. In other usages CRF is used only for that portion of the patient s data which is recorded by the investigator. 

Prior to instrumental or invasive procedures, patient-reported assessment should be performed. Patient self report, administered questionnaires, event logs or simple patient diaries are commonly used for the diagnosis of erectile dysfunction (Rosen et al. 2006). 

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