The effects of study participation on patient adherence behaviour
Research type
Research Study
Full title
An observational study of the effect of the Travalert® Dosing Aid and study participation on adherence to travoprost.
IRAS ID
135088
Contact name
Heidi Cate
Contact email
Research summary
Glaucoma is an eye condition, known to cause blindness if left untreated. Treatment with eye drops can preserve vision, but it is known that many patients do not use medication as prescribed (non-adherence). Substantial research has been undertaken in order to develop interventions to enhance medication adherence, however little progress has been made in identifying interventions with demonstrable adherence enhancing effects. \n\nFrequently studies have reported elevated adherence levels relative to retrospective observational studies. It has been recognised that research which observes patient behaviour can cause people to change their behaviour because they are participating in a study. Thus it can be difficult to obtain an accurate measure of adherence to medication within a trial setting where research bias is inadvertently introduced by experimental design errors, this is known as a Hawthorne effect. \n\nThe Hawthorne and monitoring effects found in studies measuring adherence to glaucoma medication are well documented. Electronic medication dosing monitors (EMDMs) are widely considered to be the gold standard measure of adherence but may overestimate adherence relative to usual behaviour due to these Hawthorne effects. The costs of EMDMs render them unsuitable for use in routine clinical practice and their acceptability in such contexts is unknown. The use of questionnaires to elicit information from patients is widely accepted within routine clinical practice and may therefore offer a more feasible alternative to adherence exploration than EMDM. The Identification of Medication Adherence Barriers (IMAB) is one such questionnaire designed to elicit any barriers that a patient may have to achieving acceptable medication adherence.\n\nThis observational study is therefore designed to identify the magnitude of adherence over-estimation due to Hawthorne effects, the effect of EMDM on patient behaviour and to examine the IMAB in both the usual clinical care environment and study environment.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0256
Date of REC Opinion
25 Sep 2013
REC opinion
Further Information Favourable Opinion