Abstract
Introduction
Many people require eye drops administered daily, yet many do not instil them as prescribed. This can be due to physical difficulty managing the delivery device yet little research has focused on this.
Methods
Participants from ophthalmology and rheumatology clinics at hospitals within two regions in Scotland (n = 206) were recruited and asked to complete a questionnaire about eye drop use and difficulties they experienced. Binary logistic regression was used to assess the independent relationship between key explanatory variables and the major outcome variable, which was difficulty in administration.
Findings
It was found that 62% of people who attended a rheumatoid arthritis (RA) clinic reported difficulty instilling eye drops and that they were four and a half times more likely to have difficulty than people who attended an ophthalmology clinic. A greater proportion of women and younger people attended the RA clinics than the ophthalmology clinics; however, the reasons given for having difficulty and the level of adherence did not differ between the two groups.
Conclusion
The number of people newly diagnosed with RA is increasing worldwide, particularly among women, and many need eye drops. Experiencing difficulty instilling them is therefore a significant international health issue.
Introduction
Concerns that patients do not administer eye drop medication as prescribed have been investigated repeatedly; however, few studies have focused on whether the patient can use the delivery system correctly (Robin, 2010). A number of recent studies have reported the difficulties experienced by people who are required to self-administer eye drops on a regular basis (Gupta et al., 2012; Kerr et al., 2013) and research has focused predominantly on ophthalmology patients who have glaucoma (Budenz, 2009). People with rheumatoid arthritis (RA) are particularly predisposed to dry eye syndrome (Foulks, 2008) which can cause severe discomfort and affect their quality of life (Moss et al., 2004). For example, people with dry eye syndrome have reported that the symptoms prevent them from reading, watching television and using a computer (Miljanović et al., 2007). In order to manage the troubling symptoms people frequently instil eye drops as often as four times a day (Friedman, 2010). However, reduced fine motor capability can make the process of squeezing the eye drop dispensing bottle difficult, if not impossible (Wolfe and Michaud, 2008).
Literature
Literature regarding eye drop administration was accessed using Medline, CINAHL, EM-Base, Cochrane and the Johanna Briggs Institute. The search was limited to papers written in English and no date limitation was applied. Keywords entered included glaucoma, dry eye syndrome, Sjogren’s syndrome, keratoconjunctivitis sicca, ophthalmic solutions, eye drop, eye medication, administration topical, medication adherence, compliance, non-adherence, arthritis rheumatoid.
To date there has been only one published research article that has focused on this patient group and eye drop administration (Averns et al., 1999). Averns, Hall and Webley found that 37% of people with RA who were undergoing outpatient follow-up had had symptoms of dry eye syndrome for at least 3 months at some time and 25% were currently symptomatic. It was evident that many patients had difficulty using eye drops due to problems aiming and squeezing the bottle (Averns et al., 1999). In an assessment of 30 people with current symptoms, the authors found that an Opticare device improved the ability to squeeze out drops and get them in the eye (Averns et al., 1999).
While the prevalence of RA is not extremely high (1–2% of the population), these people are a sizeable population group worldwide (Arthritis Research UK; Australian Government, 2009) and are often referred to occupational therapists for assessment and support. Given that a substantial number of people with normal joint functioning and reasonable dexterity experience difficulty in handling and squeezing eye drop containers (Gupta et al., 2012), it is very likely that correct eye drop administration for people with RA who have muscle weakness is problematic. This is a significant issue, because dry eye syndrome causes a great deal of discomfort (Le et al., 2012), and when it goes untreated it is likely to further increase the burden of RA and negatively influence the quality of life experienced by those affected.
People with RA who experience dry eye syndrome were recruited into this study. The primary aim was to determine the prevalence of difficulty in eye drop administration and to compare and contrast their experience with that of people who attend an eye clinic for conditions such as glaucoma. The secondary aim was to examine the relationship between participant and treatment characteristics and difficulty in administering eye drops.
Method
Setting and sample
This cross-sectional study recruited participants from patients attending ophthalmology and rheumatology clinics at major public health facilities within 2 regions in Scotland. In Region 1 (total population ≈ 800,000), during July and August 2012 a total of 11,556 patients were seen at the ophthalmology clinic (mean = 5778 per month) and a total of 2135 patients were seen at the rheumatology clinic (mean = 1067 per month). In Region 2 (total population ≈ 359,000), In Region 2 (total population ≈ 359,000), in July and August 2012 at total of 4349 (mean = 2175 per month) patients were seen at the ophthalmology clinic and a total of 973 (mean = 485 per month) patients were seen at the rheumatology clinic.
Summer and autumn months were chosen for data collection to avoid poor attendance due to adverse weather conditions. Twenty-three clinics were identified across the two regions (Region 1: ophthalmology (n = 5), rheumatology (n = 6); Region 2: ophthalmology (n = 8), rheumatology (n = 4)). Each clinic was scheduled to last for up to 3 hours depending on the number of appointments made. All adults who were prescribed eye drops and could speak and understand English were considered eligible for inclusion in the study. The numbers of people attending at each rheumatology clinic was smaller, and the proportion of eligible people also less, than those attending at each ophthalmology clinic. Of the 223 people who were eligible, only 17 declined to participate. The reasons given for non-participation included: in a hurry (n = 3), communication problems (n = 2) and don’t want to participate (n = 12).
Procedure
Specialist nurses and clinical managers were contacted in each centre to identify which clinics would be best suited to recruit participants based on number of consultants working and number of patients booked. The medical staff were also consulted and permission was granted to speak with their patients. Participants were recruited by experienced research nurses while they waited for their consultation at the ophthalmology or rheumatology clinics. Every person who met the inclusion criteria and was present in the waiting room was approached. Informed, written consent was obtained and the person was asked to complete the questionnaire and return it to the research nurse. The research nurses made themselves available to read questions and complete the questionnaire for any patient who had difficulty due to impaired vision or poor writing. A very small number of patients indicated that they would prefer to take the questionnaire home to complete it. They were issued with a stamped addressed envelope and asked to post it to the researchers after completion.
Instrument
Validated questionnaires about eye drops use were considered (Bechetoille et al., 2008; Kholdebarin et al., 2008; Nordmann et al., 2007) but found not to focus on the factors of particular interest in this study. Therefore, a questionnaire was developed specifically for this purpose. The questionnaire design was informed by: previous research; speaking with people who use eye drops across a range of ages; feedback from an expert panel consisting of two consultant ophthalmologists, two ophthalmology nurse specialists, two hospital pharmacists who dispensed eye drops and two research nurses. Content and face validity was established through consultation with the expert panel. The questionnaire was piloted with ophthalmology and RA patients and revised to improve specificity, readability and response burden prior to implementation.
The questionnaire consisted of 22 questions which assessed: demographic characteristics (Stryker et al., 2010); awareness of what condition was being treated and knowledge of the disease (Cook et al., 2010); frequency of eye drop use; adherence to the prescribed dose and reasons for not doing so (Kass et al., 1986); number of eye drop types prescribed; duration of eye drop use (Balkrishnan et al., 2003); difficulty in administering eye drops and reasons why (MacLaughlin et al., 2005); satisfaction with eye drop dispenser (Regnault et al., 2010); information sources about administration technique and helpfulness of instruction (Sleath et al., 2008); confidence in administering medication (Nordmann et al., 2007); assistance with the administration of eye drops; the use of, and satisfaction with, administration aids (Kahook, 2007).
Statistical analysis
With the effective sample size the study had over 80% power to detect a 60% difference in prevalence of difficulty in administering eye drops between ophthalmology and rheumatology patients with a 5% probability of incorrectly rejecting the null hypothesis that there was no difference. Following data entry all variables were surveyed for incorrect codes and appropriate corrections were made. All missing data were left as missing. The prevalence of all variables was calculated for ophthalmology clinic attenders and RA clinic attenders, and compared using chi-square. Odds ratios were calculated to assess the bivariate relationship between key explanatory variables (gender, age, clinic type, service provider, years of treatment, the provision of professional instruction and level of confidence in administering drops) and the major outcome variable (difficulty in self-administering eye drops). Binary logistic regression was then performed to assess the independent relationship between key explanatory variables and the major outcome variable. Statistical significance was set at a minimum of p < .05. Statistical analysis was conducted using SPSS software.
Results
Prevalence of participant demographics, condition and eye drop use.
Chi-square difference in prevalence: *p-value < .05, **p-value < .01, ***p-value < .001
Table 1 shows that 59% of those who were attending the ophthalmology clinic were female compared with 85% who were attending the RA clinic (p < .01). Age also differed between the two groups with 48% of RA clinic attenders aged between 31 and 60 years compared with 21% of ophthalmology clinic attenders (p < .001). Most RA clinic attenders were recruited from Region 1 (83%) as were ophthalmology clinic attenders (65%) (p < .05). While the great majority (73%) of RA clinic attenders had dry eye syndrome, 20% had glaucoma and 7% had some other condition. The prevalence of conditions reported by ophthalmology clinic attenders was somewhat different (p < .001) with 61% having glaucoma, 24% dry eye syndrome, 8% having glaucoma and dry eye syndrome and 7% having some other condition. Years of treatment, frequency of eye drop administration, number of different medications, help from a family member or friend and confidence with self-administering drops were not significantly different between the two groups. While 9% of RA clinic attenders compared with 4% of ophthalmology clinic attenders reported that they were not confident with self-administering drops this difference was not statistically significant at p < .05.
Prevalence of difficulty and adherence in using drops.
Chi-square difference in prevalence: *p-value < .05, **p-value < .01, ***p-value < .001
The prevalence and source of professional instruction and use of an eye drop administration aid were also compared between ophthalmology and RA clinic attenders. A slightly higher proportion of ophthalmology clinic attenders had received professional instruction in the administration of eye drops (56%) compared with RA clinic attenders (42%). For most participants the instruction was given by a nurse (67% and 53%, respectively) or a doctor (23% and 21%, respectively). Most participants who had received instruction reported that it was very helpful or quite helpful (98% and 94% respectively). Only 8% of ophthalmology and 7% of RA clinic attenders had ever been offered an eye drop administration aid. Of the ophthalmology clinic attenders 40% reported that the aid was not helpful and 80% said they were dissatisfied or very dissatisfied with it. For RA clinic attenders 33% reported that the aid was not helpful while 100% were either dissatisfied or very dissatisfied.
Relationship between participant and treatment characteristics and difficulty in administering eye drops.
p-value < .05, **p-value < .01, ***p-value < .001
Discussion
The aim of this study was to estimate the prevalence of difficulty experienced in eye drop administration by people who have RA and to compare this with the prevalence of difficulty experienced by people who administer drops for eye conditions, such as glaucoma. We found that 62% of people who attended an RA clinic reported having difficulty instilling their eye drops and that they were four and a half times more likely to have difficulty than people who attended an ophthalmology clinic. We also found that a significantly greater proportion of women and younger people attended the RA clinics than the ophthalmology clinics; however, the reasons given for having difficulty and the level of adherence did not differ between the two clinic groups. As to the relationship between participant and treatment characteristics and difficulty in administering eye drops, we found that, other than the type of clinic attended, the only other factors associated with difficulty were 6 or more years of treatment and a low level of confidence reported in administering drops. While women were more likely than men to have difficulty in unadjusted analysis, female gender, old age or a lack of professional instruction in administering drops were not associated with difficulty in administering drops in adjusted analysis.
To our knowledge, the prevalence of difficulty experienced by people with RA in administering eye drops has not been reported previously. In the only published research that has focused on eye drop administration by people with RA, Averns and associates stated that many people had problems (Averns et al., 1999). Given this previous research, anecdotal evidence and an understanding of the mechanics of squeezing an eye dropper container, the high proportion of 62% of people with RA experiencing difficulty in this study is unlikely to be an over-estimate. It does concur with one other study (Hennessy et al., 2010) that found that applying the correct number of drops is an issue for over 50% of people who have arthritis. Conversely, Kerr and associates (2013) surveyed people diagnosed with glaucoma to explore satisfaction with ocular medicines and found that co-morbidities such as arthritis did not predict difficulty instilling eye drops.
The finding that people attending a rheumatology clinic were four and a half times more likely than people attending an ophthalmology clinic to experience difficulty administering eye drops is another result that has not been previously reported. In this study, 31% of people attending an ophthalmology clinic reported difficulty putting eye drops in.
Although only one previous study has focused on people with RA and eye drop administration (Averns et al., 1999) it is well known that successful, accurate administration requires manual dexterity, eye hand coordination and good vision (Moore et al., 2014). This task, therefore, poses particular challenges for people with RA in terms of sufficient strength and dexterity to handle and squeeze the bottle, which is vital to administration of eye drops with the current delivery system. Observation of people instilling eye drops has demonstrated that as they reach the limit of their capability to exert pressure on the bottle they are likely to shake and further decrease the chance of getting the drop in (Winfield et al., 1990). The results of this study also showed an association between female gender and difficulty, and although this was not upheld in adjusted analysis it does have clinical significance for this population group as between two and four times more women suffer from RA than men in the United Kingdom (UK) and Australia (Arthritis Research UK; National Institute for Health and Clinical Excellence, 2009) Dzeidzic and associates (2007) have previously studied hand function in people with arthritis and found that women had more limitations than men.
It is also noteworthy in this study that the factors associated with experiencing physical difficulty did not differ significantly between those who attended an eye clinic and those who attended a rheumatology clinic; however, handling and squeezing the bottle and getting the lid off were reported by a greater proportion of people with RA. Kerr and associates (2013) found that almost a third of participants reported that putting drops in was difficult. They found that the main issues for people were opening the bottle, getting drops in the eye, knowing how much was left in the bottle and remembering to instil the drops.
An association between having difficulty and using eye drops for a longer duration was also evident in this study, which supports findings from previous research (Donnelly, 1987). Poor compliance with eye drop administration has been a focus of attention for many years and some conclude that providing education is the solution (Kholdebarin et al., 2008; Sleath et al., 2008), and yet less than half of the people in the present study who attended the RA clinic had received any professional instruction. Nevertheless, it is evident that even with high motivation to follow instructions and get the drops in some people still cannot manage. While aids are available to assist with instillation, people who reported using an aid in this study did not find it helpful.
Self-reported adherence was similar between the groups and forgetfulness the commonest reason for non-adherence, which has been reported before (Chawla et al., 2007; Stryker et al., 2010). Other research has suggested an association between adherence and ease of use (Nordmann et al., 2007) but no such association was found here, with many people in both groups reporting good adherence. Self-reported adherence has, however, been questioned, especially where this is non-intentional (Hahn, 2009). Stone and associates (2009) found a disconnect between people’s perception of successful administration and what really happened. When observed, less than a third of people actually instilled a drop successfully without the bottle tip touching the eye (between 22% and 31%). Gupta (Gupta et al., 2012) and Robin (Robin, 2010) also observed high proportions of people failing to instil drops as prescribed and this may well lead to them giving up in frustration. Dry eye syndrome can cause people a great deal of discomfort and has also been found to influence people’s confidence (Friedman, 2010). The results in this study show that lack of confidence when instilling drops was associated with experiencing difficulty. People who have RA place high value on being in control and being able to self-manage their care (van Eijk-Hustings et al., 2013). It is therefore important for them to have confidence in their ability to self-administer eye drops and relieve a troubling symptom.
Other research suggests an association between older age and reported difficulty instilling eye drops (Kerr et al., 2013); however, this was not supported in this study. More people who have RA had difficulty, and yet a higher proportion was under 60 years of age (48%). Difficulty could therefore be attributed to other factors such as reduced strength and fine motor skills as opposed to aging.
This is the first study to report the prevalence of difficulty in the self-administration of eye drops for people with RA who have dry eye syndrome. We found that the prevalence is high and much greater than for people who have eye conditions, such as glaucoma. Given that the number of people newly diagnosed with RA is increasing worldwide, particularly among women (Arthritis Research UK), and that dry eye syndrome negatively impacts quality of life, this is a significant international health issue. While the present study has a number of strengths, it is not without limitations. While the response rate was high (92%), the non-random method of sampling from selected clinics means that sampling bias cannot be ruled out. It is possible, although very unlikely, that those who attended the clinics on days when the data was collected were different in some way from those who attended on other days. It is also possible that those who attended an RA clinic are more likely to have difficulty managing their RA, generally, than those who did not, which would give rise to an over-estimate of the prevalence of difficulty in the self-administration of eye drops. Furthermore, it is possible that bias was created because some people who attended an ophthalmology clinic also had RA or some other form of arthritis. A more significant limitation that has become evident to the researchers following data analysis and interpretation is that too few detailed questions about the handling and squeezing of the eye drop container were asked. In this study the questionnaire was assembled using questions taken from the published literature. Future studies that focus on the difficulties experienced by people with RA should ask these detailed questions so as to better inform the development of suitable interventions.
Conclusion
Many people who have RA experience dry eye syndrome and this significantly impacts the lives of suffers and reduces their quality of life. Providing a more effective way for people with RA to self-manage symptoms of dry eye syndrome is very likely to significantly improve their quality of life. Eye drops can only be effective if people are able to instil them successfully. This is a significant issue that should be brought to the attention of occupational therapists as patients with RA are often referred to them for assessment, advice and support. More research is required to better understand the problem so that measures can be put in place to make instilling eye drops easier for everyone.
Key messages
Many people who have dry eye syndrome as a result of rheumatoid arthritis have difficulty instilling their prescribed eye drops. Occupational therapists are well placed to identify reduced fine motor capability and associated difficulties experienced by patients and to ensure that prescribing physicians are made aware of this. Measures should be put in place to make it easier for people with RA to instil eye drops.
What the study has added
This is the first study to report the prevalence of difficulty in the self-administration of eye drops for people with RA who have dry eye syndrome.
Footnotes
Research ethics
The study was approved by the Edinburgh Napier University Faculty of Health, Life and Social Sciences Ethics and Governance Committee, 27 April 2012.
Declaration of conflicting interests
The authors confirm that there are no conflicts of interest.
Funding
This work was supported by Edinburgh Napier University (UK). The authors also acknowledge the support of NHS Research Scotland (NRS), through Edinburgh Clinical Research Facility