Interviews were performed between December 2005 and January 2006.
Therapeutic compliance is a major factor in the treatment of glaucoma and prevention of blindness. However, compliance remains poor in this disease area; patient satisfaction has been identified as being one of the causes [28
]. Based on these observations, we have developed a satisfaction questionnaire on eye-drop treatment that will help identify patients at risk of being non-compliant.
Qualitative analysis of pooled data from English and French patients' and clinicians' interviews revealed six major concepts. Some of these had already been addressed and gathered from the preliminary literature review, but interviews also allowed the elicitation of more emotional aspects by placing the patient in the psycho-sociological context of the disease. The conceptual framework is presented in Figure . Concepts extracted from the clinicians' and patients' interviews are presented in the following sections, and are illustrated with selected citations from the interviews. Where French verbatim was included, this was translated into English by a bilingual English speaking native. This verbatim is annotated with an asterisk in the text.
Conceptual framework for the Eye Drop Satisfaction Questionnaire.
According to the clinicians' interviews, "non-compliant (patients) are more often men*", a "retired 'old man' is more compliant*", and "non-compliant (patients) are more often young*". Patients reported physical difficulty in self-administering drops ("the actual drop itself can be difficult to put in"; "to put the drops in by myself would be difficult*", "Yes, perhaps for people who are unsteady; this is not my case*"), which could result in missing the eye ("quite often it falls on the eye lid and trickles away so I have to do it again"), and their discomfort in having to put things in their eyes: "I hate instruments that get close to the eyes*". Related to these remarks may be patients mentioning that the presence of somebody (spouse, husband or external help) would facilitate this step ("my mother applied the drops to my father's eyes*"). Clinicians also expressed the discomfort and difficulty of the drop instillation process ("they just seem to say that it's hard to look in the mirror and hold one eye at the same time as putting a drop in-so it's the coordination of the whole thing – very rarely someone says that the bottle itself is a problem, but that's rare"; "they find it hard to put them in themselves"; "if someone was coming in regularly to help them put the drop in they would be able to do it"), and have observed that "plenty of those people will have them put in by their wife or spouse". Factors related to travel, whether professional or personal, constituted another major reason of non-compliance with the treatment. Some patients reported difficulties in having to remember to take their bottle when they were away: "always having my bottle with me", "even in another country", "I have forgotten them when I have been away from home". Clinicians also indicated that "professional life makes the follow-up of the treatment difficult*". A few patients explained that they were compliant with their treatment because a person in their family or friends had previously had glaucoma ("My dad having had glaucoma that was badly treated. He was 80 years old and maybe that at this age, you have other priorities. I knew I had to be very careful and pay great attention to my condition*"). Finally, clinicians reported that non-compliance could be explained by "the patients' attitude first of all, and usually they are some other issues going on that make them not bother to put the drops in".
Thus, patient characteristics including socio-demographic criteria such as age and gender appear to have a direct impact on eye-drop treatment compliance. Their level of education also has an impact (data not reported). In particular, the marital status seems to be an important factor in compliance; the presence of a partner, or any external help, is a motivating factor for patients, either as a reminder or as a direct participant who would administer eye-drops. Previous glaucoma history in patients' entourage may help in increasing their compliance, as the patient could then be aware of the effects that might result from an inappropriate treatment. Physical difficulties including palsy, discomfort putting things in eyes, and blink reflex when instilling the drops are a barrier regarding the patients' compliance with eye-drop treatment. Patient compliance is also related to the time they can spend administering their drops during the day. Lastly, travel or any modifications in patient habits often result in forgetting to use their medication, and thus have a negative impact on compliance.
Daily frequency of the treatment was often given by patients as having an impact on their compliance: "three (drops) in the evening and two in the morning with a ten-minute pause between the two drops", "the one (drop) during the day, I might forget it", "the one in between I might take it at dinner time and might take it at 4 o'clock". Side effects and feelings of discomfort resulting from the treatment were also reported by patients and clinicians: "It stings. I don't want to take my drops tonight", "It stings and it makes my eyes red. I'm going out tonight, I don't want to have red eyes*", "It burned when I applied it. I had puffy eyes, red eyes*".
Patients' compliance and/or satisfaction with the treatment may be influenced by the characteristics of the treatment itself, such as the frequency of daily intake, and the time of intake. The amount and intensity of the treatment side effects are major factors: the greater and more painful the side effects, the less compliant the patients. Finally, satisfaction is closely related to compliance; indeed, if the patient is satisfied with the treatment in its overall features, then he/she will be more compliant.
Sharing information about the disease and the treatment with their clinician and checking-up on the efficiency of the treatment have been mentioned by most patients as motivating factors for compliance and/or satisfaction: "(About change in the visual field) without an ophthalmologist it is impossible to know about it on your own*", "I know because every 6 months, I have an appointment with my clinician and he measures my ocular tension. And I noticed that from 17, I stabilized at 10 for each eye and it's not changing anymore. For me, this is a good result*"; A few patients said that they would be encouraged to continue their treatment if their physicians were willing to train them how to administer their medication and gave regular check-ups. The attention paid by the clinician and positive feedback were also reported by patients as motivating factors ("I consulted a specialist who cheered me up, he told me that if the pathology is treated early enough, it couldn't go badly*"; "I was diagnosed very early. It's lucky the ophthalmologist had a good reaction, because some of them think that you are making it up*").
A good relationship, including care, training, feedback and regular check-ups with their clinician is essential to patient satisfaction, and is likely to result in improved compliance. This may be linked to the patients' difficulty in evaluating the efficacy of their treatment themselves because of the elusiveness of the disease. Only a clinician (ophthalmologist) can inform patients about a change in their medical condition (an improvement, deterioration or stabilisation). A relationship based on trust and regular check-ups of patients by their clinician is therefore necessary to motivate patients to take their treatment.
The trouble the patients have remembering to take the treatment, ("the constraint is thinking about it*"; "You get in, you fall asleep, you wake up later and can't remember if you have taken your drops") and the burden of administering drops in the eyes ("I can drive but it bothers me at night, the car lights...that's why we stopped going out in the evening*", "The only trouble is remembering to use them") were just part of the list of constraints that may result in not taking the medication. Patients expressed their doubts about the effectiveness of the treatment because of the absence of an immediate medical deterioration in their condition if they don't take their drops ("I didn't take all [my drops]) last week and feel fine"), because of the absence of a fast and noticeable improvement in their vision ("The difficulty is knowing if the treatment is working*"; "sometimes because of poor efficacy of the drops"). One patient reported his non-compliance with any medication ("I don't actually like taking medication, full stop"). Fear is very frequently reported as being a factor contributing to the non-compliance of patients. For clinicians, the association of glaucoma with blindness was the most frequent fear found in glaucomatous patients ("I think their first fear is 'am I going to go blind or not?"). For the majority of the patients, the fear of going blind was also the biggest fear linked to their medical condition ("Yes, scared of going blind, more than of being in a wheelchair*"; "I was worried at first, the fear of going blind*"). Fear of surgery was also brought up. Clinicians reported that they used these fears to incite patients to be compliant with the eye-drop treatment ("Once they have gone through that, then you can tell them about the medical treatments – we tell them that most of the time the drops work"; "Fear of surgery is a real fear; We use that to make sure they put the drops in"). Equally, having to take a treatment for life was another factor that patients indicated: "At the beginning, it makes me think, a lifelong treatment is never something pleasant*".
Thus, patient experience with eye-drop treatment may influence their compliance with it. Especially, compliance is likely to be jeopardised if the treatment is perceived as a constraint or if the patient has doubts about the effectiveness of the treatment. Furthermore, fear of the disease may also be a barrier to compliance: if the fear regarding the illness and its consequences is too high, anxiety may override the defensive mechanisms and lead to a denial of the disease that could ultimately result in renunciation of the treatment.
Clinicians reported that patients have no or incorrect knowledge about glaucoma and its symptoms ("A strong non-compliance factor is the non-understanding of the disease by the patient; there is no need to take treatment, I don't feel symptoms*"; "Just preconceptions they have about going blind basically and that is associated with the word glaucoma"). Patients often indicated the lack of information regarding their disease: "I have no information*", "As with a lot of treatments, in medicine, they are not very talkative about why you have to take a treatment, what it does, the inconveniences, you don't know any of these*". Patients confessed their attempts to self-diagnose their disease: "I read in a book about glaucoma symptoms about seeing a halo around the light and thought, I have that symptom, so went to see the doctor", "Oh yes because I always – they have a leaflet to tell you exactly what they are doing for you and what the side effects might be, if you have any, which was good, nothing to get upset about"), and their need to be informed (talking about information: "No, not much. I'd like to have more. But we read a lot of things. My sister is also under treatment*".
Patients' knowledge about the disease treatment also influences their compliance: patients will be satisfied if they are regularly informed about their illness and in turn will be more compliant with their treatment. To fully understand the importance of being compliant with the treatment, patients need to understand the reasons for which they have to follow a treatment, especially when the treatment has constraints. Consequently, clinicians play a major role by supplying this information, which underlines the need for a good relationship between patients and clinicians.
Patients mentioned forgetting to take the treatment or deliberately interrupting it: "Sometimes I don't want to. I told you it happened 3, 5, 10 times maximum in 3 years... There is no reason... I think I did it consciously, so few times in 3 years; it's neutral (without consequences). ... Because I don't want to! I have children, and when they were at school, I always told them – during the school year you can take 2 mornings off no more...I do the same with [name of the product]*". Other patients said they have developed routines and organisational means to help them remember to take their treatment: "When I get up in the morning I usually have a wash and come back into the kitchen and put one drop in my right eye"; "Well, I keep the bottle on the bedside table so that usually it reminds me"; "You just get into the routine – twice a day and it's no big deal". But often, patients related these routines to a necessity, and as such defined them as an obligation: ("But I have to admit that drops every evenings, it's a constraint*"). The repetitive aspect of the treatment could also help the patient to accept the treatment, as reported by a patient: "No, it's not restrictive because one drop in each eye once a day before going to bed, it's a reflex, it's a habit and it only takes 8 seconds*". The inconvenience of the application device was raised as a problem for correctly measuring out the drops ("the bottles are not too bad. It's a mass-produced drug and with some of them, you have to be careful because there are at least 2 to 3 drops that come out*"). Its inconvenience was also noted because of the difficulties in using it for elderly people (talking about elderly people: "The bottles are very small and so, when they press them they don't have the same flexibility that we have in their fingers, and also, to have to lean back your head can result in dizziness, they may fall. That elderly people are non-compliant with these kinds of treatments doesn't surprise me*"), or because of their difficulty in administering the drops by themselves: "I was doing it myself, but watching the mirror is not very handy and I was missing my eyes. However, for some other patients, "the bottle is not too badly designed*".
Interaction between patients and treatment is another factor to consider in patients' treatment compliance. On the one hand, routines may help the patient to be compliant, but on the other hand, these same routines might be perceived as a constraint. Non-compliance might thus be a way for patients to re-appropriate their life and to cope with the anxiety and fear they associate with their disease. The convenience of the application device and its ease of use are an other major factor in satisfaction and/or compliance with the treatment.
Evaluation of the content validity
Cognitive debriefing was performed by interviewing six patients with glaucoma (n = 4) or OHT (n = 2), in France and in England. Overall, the majority of the items were well understood and accepted by patients who made few remarks regarding their difficulty in understanding and completing the questionnaire. Twelve items were deleted as they were not relevant or were redundant, and twelve questions had to be reworded or slightly modified in order to make them clearer for the patients. Following experts' comments, the order of the items was also modified in order to facilitate the completion of the questionnaire. The definition of the concepts was also refined and restructured. These concepts and the associated subconcepts are presented in Table .
General concepts and subconcepts of the final questionnaire
The resulting EDSQ questionnaire, available in French and English, contains 46 items, assessing 6 domains: 1/Patient characteristics (16 items, including items on age, gender, family and working status, travel, physical difficulties and apprehension), 2/Treatment characteristics (4 items, including items on frequency and time of intake, multiplicity of treatments and side-effects), 3/Patient-clinician relationship (6 items, including items on frequency of visits, satisfaction with frequency of visits, training, satisfaction with clinician care and impact of good feedback and follow-up), 4/Patient experience (7 items, including items on perceived constraints of the treatment, fear of the disease, confidence in the treatment, forgetting the treatment, difficulty in taking drops and thinking constantly about the disease), 5/Patient-treatment interaction (9 items, including items on the ease and convenience of the administration route, set up of routine, break in the treatment, and self-assessment of compliance), and 6/Patient knowledge (4 items related to the information received by the patient on the disease and the treatment). For ease and clarity, the questionnaire was divided into two distinct parts, the first part dealing with socio-demographic items, and the second with disease-related questions. Respondents answered each item using either a dichotomous scale (Yes/No) or a 5-point Likert type scale ranging from "not at all" to "extremely" or from "never" to "always".