Compliance electronic monitoring

Bumier M, Schneider MP, Chiolero A, Fallab Stubi CL, Brunner HR. 2001. Electronic compliance monitoring in resistant hypertension the basis for rational therapeutic decisions . J. Hypertens. 19 335-341. 

Boutelant S, Dutrey-Dupagne C, Vaur L et al (1995) Electronic compliance monitoring and antihypertensive coverage evaluation. Abstracts of the Seventh European Meeting on Hypertension, Milano, Universita degli Studi di Milano. Ricerca Scientifica ed Educazione Permanente Suppl 103, 25(103). 

Kruse W, Nikolaus T, Rampmaier J et al (1993) Actual vs. prescribed timing of lovastatin doses assessed by electronic compliance monitoring. Eur J Clin Pharmacol 44 211-15. 

The AERx, developed by Aradigm (Hayward, CA), is a metered dose liquid inhaler designed to deliver various pharmaceutical compounds to the peripheral lungs. The system, as shown in Fig. 10, consists of a unit dose disposable container equipped with a nozzle array, a piston assembly, and electronics associated with breath actuation and compliance monitoring functions. ... 

De Klerk E, van der Linden SJ. Compliance monitoring of NSAID drug therapy in ankylosing spondylitis, experiences with an electronic monitoring device. Br J Rheumatol (in press). 

However, more sophisticated monitors require a power source, usually batteries, so that more complex information can be recorded and transcribed. This also requires the use of electronics that are becoming more common but a mass-produced electronic chip will be necessary for low cost. Hence a number of compliance monitors at present have been developed within companies for internal use, including clinical trials, but are relatively crude prototype devices. 

Advances in measurement have freed the estimation of patient compliance from its long-standing dependence on methods easily manipulated by patients, whose reluctance to acknowledge poor compliance contributes to self-reporting bias, documented in many ways. The years 1986-1987 saw the introduction of chemical marker and electronic monitoring methods, which provide different but complementary estimates of the time history of dosing by ambulatory patients. These advances have been extensively reviewed (Feinstein, 1990 Pullar and Feely, 1990 Urquhart, 1990 Cramer and Spilker, 1991 Bond and Hussar, 1991 Vander Stichele, 1991 Kruse, 1992). The gist of both methods is as follows. 

Patient data collection is an extremely critical component of a value-added service. The information collected provides pharmacists with important baseline and monitoring parameters for patients. The amount and type of information needed from the patient or other health care providers may differ depending on the service, but nonetheless, this information is the foundation on which the other components of the service are built. Forms can be developed to help pharmacists collect this information (see Figs. 25-2 through 25-4). In addition, some consideration should be given to how this information will be stored (e.g., paper charts or electronic patient database). The information that should be collected from the patient includes demographic information, medical history, family history, and medication history. Since some of the information may need to be collected from other providers and health care institutions, an authorization to release medical information should be signed by the patient and kept as part of the chart (see Fig. 25-5). Lastly, pharmacists should ensure that their site is in compliance with the Health Insurance Portability and Accountability Act (HIPPA) and reinforce to their patients that the information they provide is confidential and secure at the pharmacy. 

The incorporation of breath activation and/or counting mechanisms into the MDI opens the possibility of including other device features, particularly if the above-mentioned two features are achieved via electronic means. MDIs that feature data gathering technology allow the patient or physician to monitor how and when the medicine is being taken (compliance) or to monitor lung function and control the amount of medicine that the patient is taking are distinct possibilities. 

Thus, two very basic factors are (a) reliable detection of poor compliance and (b) reliable measurement of the consequences of steps taken to improve it. Given that clinical identification of poor compliance is so strongly biased toward underestimation, electronic monitoring, done in real time, is now the accepted standard. 

For the analysis of the observation period, the data saved in the electronic monitors are transferred via a communicator to a personal computer or to a secure website. With few commands, the patient s medication history can be visualized on the PC screen and then printed as a compliance report. 

Feinstein AR. 1990. On white-coat effects and the electronic monitoring of compliance . Arch. Intern. Med. 150 1377-1378. 

W. Kruse, P. Koch-Gwinner, T. Nikolaus, P. Oster, G. Schlierf, and E. Weber, Measurement of drug compliance by continuous electronic monitoring a pilot study in elderly patients discharged from hospital. I Am Geriatr Soc 40 1151-1155 (1992). 

Prior to the technical advances described below, patient compliance was vaguely defined. A typical definition might have been, following the instructions of the health care provider (Cramer 1991). With the advent of electronic monitoring methods, it has become practical to use a definition of compliance with pharmacologic and quantitative meaning... 

Whether it is a Phase II study of efficacy or tolerance, one tactic is to use a run-in or preselection period, with the aim of choosing only good compliance patients for the definitive assessment of the study end-points. The criteria for the measurement of compliance with electronic monitors in this case are (a) the ratio of the number of administrations observed to the number of intended doses and (b) the mean intervals between the administrations (e.g. a patient in a trial requiring a dose of a single tablet daily might be considered a good complier if he she took 90% of the total doses with a mean interval between doses of 26 2 hours (h)). 

Data saved in electronic monitors may be transferred and collated in larger computers the data transfer may be hard (cable) or soft (telephonic). Patients medication histories can then easily be charted using software that is not sophisticated by today s standards, and hard copy compliance reports can become part of the patient s clinical chart or case report form. 

---