- Email: [email protected]
The truth about compliance
Contact Lens and Anterior Eye, Vol. 20, No. 3, pp. 79-86, 1997
© 1997 British Contact Lens Association
Printed in Great Britain
Guest Editorial THE TRUTH ABOUT COMPLIANCE* Nathan
Efront
Abstract-- When confronted with an adverse response to contact lens wear, practitioners are often quick to 'blame the victim'. Although patient compliance may well be lacking, the reasons for this need to be considered carefully, along with all of the other possible contributing factors, if the safety of contact lens wear is to be improved. This Presidential Address briefly reviews what the contact lens Hterature has revealed about patient compliance in the context of what has been known for many years in general eye care and, indeed, general medicine. Essentially, compliance with contact lens systems is poor (40-90% of patients are noncompliant) and difficult to predict in individual patients. Neither a compliance-enhancement strategy (intense education) nor reduction of the cost of goods has any significant effect upon the level of compliance. Assessment of personality is not a reliable compliance predictor. A compliance enhancement model is proposed which encompasses the following four components: (a) the clinic and the practitioner, (b) the patient, (c) the advice that is given, and (d) the contact lens industry. KEYWORDS:
contact lens, patient, compliance, education, cost, personality, practitioner
Introduction ]~Tumerous reports of corneal ulceration in associaI ~l tion with contact lens wear in the professional~-~ and lay literature over the past decade have focused attention on the question of causation. However, the aetiology is not always obvious and the search for the answers is often confounded by vehement defences mounted by those with strong and sometimes conflicting commercial, academic and/or professional interests in the problem. As expected, ophthalmologists treating the ulcers and seeing hospital wards full of contact lens-related corneal ulceration are keen to highlight the problem and those manufacturing and distributing contact lenses and lens care solutions will staunchly defend their products. There is, therefore, a tendency to opt for a simple solution - - to 'blame the victim'! It is of course true that patients can be at fault and unwittingly, carelessly or even recklessly contribute to their own misfortune. An example of recklessness is given in Figure 1; frustrated at the realisation that his aerosol saline can had ceased to spray saline despite the fact that he could still hear saline solution at the bottom of the can - - this patient attempted to saw off the top of the can so that he could use the remaining saline. The fact that patients can effectively contribute to their own misgivings was first recognised by Hippocrates, who wrote in 400 BC "patients are often lying when they say they have regularly taken the prescribed medicine." The issue that Hippocrates was highlighting was that of compliance - - an important * This is a transcript of the BCLA Presidential Address delivered on 3 September 1996 at the Royal Society of Medicine, London. t BScOptom, PhD, DSc, MCOptom, FAAO, FVCO.
Figure 1. Reckless attempt by a patient to obtain residual solution from a can of aerosol saline (because the nozzle had ceased to function) by sawing off the top.
field of medicine that has been the subject of medical research for much of this century. In the contact lens field, studies of compliance commenced only a decade ago, with the first peer-reviewed journal article on this topic being published in 1986 by Collins and Carney# Numerous factors that can contribute to contact lensrelated problems are largely beyond the control of the patient and practitioner, such as the intrinsic safety of contact lenses and lens care solutions, environmental
79
NATHAN EFRON
factors (contact lens-related corneal ulceration is more common in the summer) ~ and personal susceptibility (e.g. atopy or diabetes). One reason for the growing interest in the issue of compliance is that it encompasses many aspects of clinical practice and it is an important defining feature of the practitioner-patient relationship. Another attraction is that compliance can be measured and perhaps manipulated so as to produce a better outcome. Sackett and Hayes6 defined compliance as "the extent to which a patient's behaviour coincides with the clinical prescription". This provides a useful working definition as it essentially defines the two key requirements of the practitioner-patient relationship that are needed in order to avoid adverse events. The aim of this Presidential Address is to (a) present a critical analysis of the issue of compliance, primarily as it relates to contact lens wear, by side-stepping the simple defence of 'blaming the victim' and examining the underlying issues, (b) describe recent research by myself and colleagues that addresses questions relating to the measurement, prediction and modification of non-compliant behaviour, and (c) develop a model for compliance in the contact lens field. That is, I seek to 'reveal the truth' about compliance! Theory of Compliance
Consequences of Non-Compliance It is worth considering the possible consequences of non-compliance because the conclusions from such an analysis provide the rationale for studying compliance. In general, non-compliance will result in the following adverse effects: • • • • •
reduction of treatment efficacy secondary problems incorrect prescribing wasting of practitioner chair time wasting of patient time.
Clearly, healthcare delivery will be enhanced if the above adverse consequences of non-compliance can be minimised or eliminated.
Prediction of Non-Compliance Many of the problems relating to non-compliant patient behaviour could be overcome if it were possible to predict which patients were less likely to be compliant. For example, one might intuitively expect highly educated patients to be more likely to be compliant because they can better understand the instructions given by their practitioner. It might also be expected that patients of a higher socioeconomic status are more likely to be compliant because they can afford to purchase all of the necessary paraphernalia and maintain a more hygienic environment. Unfortunately, most attempts at identifying such predictors have been unsuccessful. For example, Davidson and Akingbehin 7 failed to find an association, in general ophthalmological practice, between non-compliance
80
and the following personal and sociological characteristics: • age •
sex
• • • •
race education occupation socioeconomic status.
Interestingly, Chun and Weissman 8 were able to identify one potentially useful predictor of non-compliance relating to contact lens wear - - patient age. They found that patients under the age of 30 years and over the age of 50 years were more likely to display noncompliant behaviour. Thus, practitioners ought to be alert to compliance-related issues when dealing with contact lens patients in these age ranges.
Extent and Pattern of Non-Compliance It is not possible to simply characterise the behaviour of a patient as compliant or non-compliant, because there will be variations in the pattern and extent of noncompliance. With respect to the pattern of non-compliance a patient may be consistently or inconsistently non-compliant. An example of consistent non-compliance is a patient who never uses a surfactant cleaning solution despite being advised to do so. An example of inconsistent non-compliance is a patient who normally uses a surfactant cleaning solution but does not bother to take it away on holidays (in the interests of 'travelling light') despite being advised to always use such a product. With respect to the extent of non-compliance - - a patient may be totally or partially non-compliant. An example of total non-compliance is a patient who displays serious procedural errors in using all lens care products (e.g. saline, cleaning solution, disinfecting solution, protein removal tablets, etc.). An example of partial non-compliance is a patient who displays serious procedural errors in using some lens care products, while using other lens care products exactly as instructed. Perhaps the most difficult situation to deal with clinically is a patient who is inconsistently and/or partially non-compliant, because the non-compliant behaviour may continue undetected for some time. There is a greater likelihood of detecting consistent and/or total non-compliant behaviours at an aftercare visit. -
-
Duration of the Prescription In the general healthcare field, the extent of non-compliance has been found to be related to the duration of the prescription. For short-term medication (e.g. a 9day course of antibiotics) about 20-30% of patients will be non-compliant. Higher rates of non-compliance are found for long-term regimens: 30-40% of patients are non-compliant with preventative or prophylactic measures (e.g. using sun-protection creams outdoors in patients susceptible to skin cancer) and more than 50%
THE TRUTH ABOUT COMPLIANCE
of patients do not adhere to advice relating to long-term therapy (e.g. ongoing medication for chronic hypertension) .9,10 The prescription of contact lenses and contact lens care systems is akin to a long-term preventative measure; it is therefore not surprising that numerous studies have concluded that about 40-90% of contact lens wearers are non-compliant in at least some aspects of their contact lens care regimes. 11That is, the contact lens literature is in broad agreement with estimates of patient non-compliance documented in the general medical literature. Erroneous Contact Lens Procedures
A complete documentation of the ways in which contact lens patients have been shown to be non-compliant with their wear and care protocols is beyond the scope of this review; however, it is of interest to peruse a summary list (compiled from data reviewed by Claydon and Efron u) of the types of transgressions that can occur: • • • • • • • • •
62% keep solutions too long 40% never clean the lens case 36% irregularly clean lenses 30% do not disinfect lenses daily 30% do not wash hands before handling lenses 27% wear lenses too long 10% never rinse the lens after cleaning 8% never clean lenses 3% clean lenses in tap water.
Compliance with the Incorrect Prescription
The vast majority of practitioners endeavour to dispense the correct and proper prescription; it would be unethical to do otherwise. However, there have been well-documented cases in recent years of practitioners dispensing the incorrect prescription based on misinformation or a misinterpretation. 2,~An example of this is a recommendation to soak disposable lenses overnight in unpreserved saline solution (instead of a multipurpose disinfecting solution) based upon the mistaken belief that frequent lens replacement obviates the need for daily lens disinfection. It is sad to say that a small minority of practitioners knowingly and unethically dispense improper prescriptions, with the usual motivation being greed. An example of such a practice is the dispensing of daily disposable lenses (obtained at very low unit cost) to patients who are advised to dispose of the lenses monthly and are charged a greater fee commensurate with a monthly-replacement modality. Whether inadvertent or deliberate, incorrect prescribing is a reality that must be considered in order to provide a comprehensive analysis of non-compliance. Figure 2 is a flow diagram that reveals five possible outcomes based upon the assumption that an incorrect prescription (or incorrect advice) has been dispensed to the patient. A tick indicates the likelihood of a positive outcome, and a cross indicates the likelihood of a negative outcome.
INCORRECT PRESCRIPTION
I
I
Non-compliance I
I
I
I Deliberate I !
IC°mplianceI ~
IUnintenti°nal I I
I~rrati~,n~l~
X
X
~Iisund~rst°°dI
X
X
Figure 2. Consequences of compliance with the incorrect prescription (a tick indicates the likelihood of a positive outcome and a cross indicates the likelihood of a negative outcome). If the patient is compliant with the incorrect prescription, a negative outcome, such as the development of a corneal ulcer, is more likely. With respect to the example given previously - - a patient complies with the instruction to soak lenses overnight in unpreserved saline. Now consider the case of a patient who is non-compliant with the incorrect prescription. Non-compliance can be deliberate or unintentional. A patient can be deliberately non-compliant in a rational or irrational manner. Continuing with our example - - the decision to use a multi-purpose disinfecting solution (based, say, on previous experience), instead of unpreserved saline as advised, would constitute rational non-compliance. This should result in a positive outcome. A decision to use tap water instead of unpreserved saline as advised (a procedure that perhaps carries an even greater risk of infection), would constitute irrational non-compliance and is likely to lead to a negative outcome. Unintentional non-compliance can be due to forgetfulness or a misunderstanding of the instructions. It is unlikely that unintentional non-compliance will result in correct procedures being re-adopted because of the plethora of random and most likely erroneous procedures that are theoretically available. Compliance with the Correct Prescription
A patient being non-compliant with the correct prescription probably constitutes the classic view taken by practitioners. Consider, then, Figure 3 which is a flow diagram that also reveals five possible outcomes - - but I CORRECT PRESCRIPTION
I
I
Non-compliance I
I
I
I Deliberate ]
[Unintenti°nal I
I
IComplim~cel ~
!
~
V'
~
X
~,Iisund~rstood~
X
X
Figure 3. Consequences of compliance with the correct prescription (a tick indicates the likelihood of a positive outcome and a cross indicates the likelihood of a negative outcome).
81
NATHANEFRON this time based upon the assumption that a correct prescription (or correct advice) has been issued. K the patient is compliant with the correct prescription, a positive outcome is more likely. Now consider the case of a patient who is non-compliant with the correct prescription. An example of a correct prescription is advice to use a multi-purpose contact lens disinfecting solution. As discussed above, non-compliance can be deliberate or unintentional, and deliberate noncompliance can be rational or irrational. Rational noncompliance could be demonstrated, for example, by a decision to use a hydrogen peroxide-based disinfecting solution instead of the multi-purpose as advised. Although most practitioners would prefer that patients do not change their lens care system without prior consultation, such a change would generally be deemed to be safe and would therefore be unlikely to result in a negative outcome. A decision to use tap water (a procedure that carries a greater risk of infection) instead of multi-purpose disinfecting solution as advised, would constitute irrational non-compliance and is likely to lead to a negative outcome. Unintentional non-compliance as a result of forgetfulness or a misunderstanding of the instructions is more likely to result in a negative outcome for reasons given previously.
Compliance Enhancement Research Can Compliance be Enhanced?
Vincent12 conducted a study on a large cohort of glaucoma patients who were specifically told that if they did not comply with the instruction to instil three drops into their eyes daily they could go blind. The outcome of the study was that 50% of patients did not comply often enough, and that there was no improvement in compliance in those who lost sight in one eye. In the light of such results, it is not unreasonable to wonder whether anything can be done to improve compliance among contact lens wearers, especially in view of the fact that the consequences of non-compliance, such as the development of a corneal ulcer, carry a very low absolute risk. A more logical approach might be to assume that there will always be a certain level of noncompliance, and that contact lenses and lens care systems should be designed to have a sufficient level of redundancy, or safety margin, to account for this. Despite the above reservations, the search for viable compliance enhancement strategies needs to continue in view of the known adverse consequences of noncompliance. Below is a description of two experiments that were conducted by myself and colleagues ~3-16 in order to evaluate clinically applicable techniques for enhancing compliance among contact lens wearers. Hypothesis I: Intense initial education enhances compliance This was a 12-month study13,14 conducted on 80
patients who were randomly divided into two groups. Group ! acted as a control. All patients in this group were given the standard 'spiel' (verbal instructions), based on the findings of a survey of the usual patient 82
education delivered by practitioners in the Manchester area. 15 In addition to receiving the standard spiel, patients in Group II were subjected to a 'compliance enhancement strategy', which comprised: • watching a humorous video about compliant and non-compliant behaviour • taking a checklist of procedures to follow • putting up a poster at the point of lens care promoting and reinforcing good practice • signing a healthcare contract emphasising shared responsibility between patient and practitioner. All patients used Medalist contact lenses (38% HEMA daily-wear lenses disposed of monthly) and ReNu multipurpose solution (Bausch & Lomb, USA). All patients returned for an aftercare visit every 3 months. At the 12-month aftercare visit, all patients were examined in random order by a masked observer (who did not know the group to which each patient was assigned) and the level of compliance was assessed by questionnaire and observation of procedures. The patients were not told of the true purpose of the study (they were led to believe that they were evaluating a new brand of contact lens). Thus, this was a single centre, controlled, randomised, double-masked study. Summary results of the percentage of patients who were non-compliant with various aspects of the technique demonstration are presented in Figure 4. By inspection, it seems that the compliance enhancement strategy has been beneficial because the overall level of non-compliance appears to be lower among patients in that group. However, the overall difference was not statistically significant. Hand washing was the only procedure that improved to an extent that was statistically verifiable (p<0.05, ×2 test). Generally, it is concluded that the compliance enhancement strategy failed. It is of interest that the overall level of non-compliance ranged from about 3% to 50%, which is lower than the general estimate of 40% to 90% non-compliance with contact lens systems reported to date. 11 A possible
6O
[] Standard spiel • Intense education
¢J 50 eoEo 30 20
0
Order
Dis,
Case
Rinse
Clean
I
Hand
Figure 4. The percentage of patients who were non-compliant with various aspects of the technique demonstration after 12 months. (Order = order in which procedures were undertaken; Dis. = proper lens disinfection technique," Case = completeness of lens case care; Rinse = proper lens rinsing," Clean = thoroughness of lens cleaning; Hand = thoroughness of hand washing).
T H E TRUTH ABOUT COMPLIANCE
reason for this is that all patients were using a very simple system - - monthly replacement lenses and multi-purpose care solution - - which would be expected in itself to enhance compliance ( it should be noted, however, that this notion has yet to be scientifically validated). Although the use of such a straightforward system may have reduced the sensitivity of this study, the experiment was not invalidated because both the test and control groups used the same system. Summary results relating to the ocular response to lens wear are presented in Figure 5. As expected - because of the absence of a difference in compliance between the two experimental groups - - the intensity of initial education had no bearing on the integrity of the anterior ocular structures.
2.0 t.6 1.8 1.4I
[] Standard spiel • Intense education ]
t- 1 . 2 •~ 1.0 (5
Palp conj
Limb hyp
Bulb hyp
Corn stain
pay' group paid the full retail price of lens care products, whereas the 'nominal pay' group paid a nominal fee for their lens care products (10p per item). All patients used a multi-component lens care system comprising of the following Allergan products: LC-65 cleaner, Oxysept 2-step disinfecting and storage system, saline solution and Ultrazyme protein removal tablets (Allergan, USA),. After 4 months, all unused and part-used bottles and packages were returned and the precise amount of product used (i.e. volume of solution or number of tablets) over the 4-month trial period was determined. A calculation was also made as to the amount of product it was expected that each patient should have used based upon assumptions of correct usage (as indicated by instructions given in the product literature) and a determination of the lens wearing schedule. Figure 6 is a bar graph depicting the ratio of the actual amount of product used to the calculated amount of product used, expressed as a percentage. By inspection, patients seemed to use less Oxysept l&2, saline and Ultrazyme tablets, but more LC-65 cleaner, than expected. These apparent discrepancies were not statistically significant. What is particularly noteworthy in the context of the experimental hypothesis is that there is no significant difference in usage between the 'full pay' and 'nominal pay' groups. That is, reducing cost did not affect compliance as measured by solution usage.
Figure 5. Grading of ocular response (on a scale from 0 [normal] to 4 [severe reaction.]) a/~er 12 months. (Palp conj = palpebral conjunctiva; Limb hyp = limbal hyperaemia; Bulb hyp = bulbar hyperaemia; Corn stain = corneal staining).
Despite the 'negative' or 'no difference' nature of the results of this experiment, important conclusions can be drawn. A clear message to practitioners is that, from a compliance perspective, there is no benefit in overdoing the initial level of education given to contact lens patients. That is, a level of instruction in excess of that currently being offered, as judged from general practices in the Manchester area, is likely to be redundant in terms of enhancing compliance. Putting the issue of compliance aside - - there are other clear benefits of a thorough initial education, such as (a) raising awareness of lens types and lens care products, (b) reinforcing brand loyalty (if this is of interest), and (c) enhancing the patient-practitioner relationship. Although this study failed to demonstrate any compliance-related advantages of providing an enhanced initial instruction, previous research has reinforced the benefits of re-instruction. That is, compliance can be enhanced by constantly reminding patients of correct procedures at aftercare visits. Radford et al. ~7 demonstrated that such an approach improved the rate of compliance in one study group from 44% to 90%. This was a 4-month study 16 conducted on 59 patients who were again randomly divided into two groups. The 'full Hypothesis II: Reducing cost enhances compliance
I ~ ~,,II
-o
~
[~l
E
o~
v
Oxy I
Oxy 2
LC-65
Saline
U'zyme
Figure 6. Ratio of the actual amount of product used to the calculated amount of product used, expressed as a percentage. (Oxy 1 = Oxysept 1; Oxy 2 = Oxysept 2; LC-65 = LC-65 Daily Cleaner," Saline = saline solution; U'zyme = Ultrazyme).
The percentage of patients deemed by demonstration to be non-compliant with respect to a series of key lens care procedures is depicted in Figure 7. Again, there was no statistically significant difference between the 'full pay' and 'nominal pay' groups. The overall level of compliance was very good, which probably relates to the short-term period of follow-up; i.e. a 4-month period probably did not allow sufficient time for bad habits or incorrect practices to manifest. An interesting ramification of this study is that it arms the contact lens solutions industry with a rationale for resisting pressure to reduce the cost of solutions, from a compliance-enhancement perspective, on the basis that reducing solution cost had no beneficial effect upon compliance. There may, however, be other sensible reasons for reducing the cost of care products that relate, for example, to sales and marketing concerns.
83
NATHAN EFRON
60 ~ 50 o
• "When I get what I want, it's usually because I am lucky". • "How many friends I have depends on how nice a person I am". • "My life is chiefly controlled by powerful others". • "Whether or not I get into a car accident depends mostly on the other driver".
[ [] Full pay [ • Nominal pay
c m
~. 4o E o 30 ? c0 20 Z
Case
Order
Dis.
Hands Clean
Rinse
Figure 7. The percentage of patients who were non-compliant with various aspects of the technique demonstration after 4 months. (Case = completeness of lens case care; Order = order in which procedures were undertaken; Dis. = proper lens disinfection technique," Hand = thoroughness of hand washing," Clean = thoroughness of lens cleaning; Rinse = proper lens rinsing).
It is certain that had this experiment been conducted the other way round - - by determining the level of compliance as the cost of care products is increased - - it would have been possible to determine a threshold cost above which patients become dangerously non-compliant. For example, it is unlikely that many patients would be persuaded to pay £100 per bottle of lens cleaner no matter how emphatic the practitioner was as to the importance of lens cleaning. Of course, it is not possible to conduct such a study in the real world. Can Personality be U s e d to Predict NonCompliance? As discussed previously, attempts at predicting which patients are likely to be more compliant, based upon demographics and socioeconomic features, have largely failed. One approach that has not been investigated is the possibility that measurement of certain personality traits can be used to predict a likelihood or otherwise of compliance. Various psychological tests have been devised and discussed in the psychology literature, and some of those of potential relevance to health care have been reviewed by Claydon.1~ One test that has attracted considerable attention is the '16 Personality Factor' (16PF) Inventory.18 In essence, the theory underpinning this test is that personality traits can be divided into the following five categories (each defined in terms of personality extremes): • Surgency - - extroversion v introversion • Agreeableness - - friendly compliance v hostile noncompliance • Will - - conscientious v 'carefree' • Emotional stability-- neuroticism v emotional stability • Intellect - - high v low. The 16PF test is administered by asking each subject to complete an extensive questionnaire comprising a series of statements, each of which must be assessed as to the extent to which the subject agrees or disagrees (on a scale of 0 to 5). Examples of such statements are as follows:
84
Additional analysis can be performed on the data to ascertain secondary personality traits such as 'locus of control'; that is, whether the subject is 'internal' (in control of one's self) or 'external' (controlled by others). The level of compliance with a simple contact lens regime was measured on 48 contact lens wearers using the demonstration and questionnaire techniques described above. 1S All patients used Medalist contact lenses (38% HEMA daily-wear lenses disposed of monthly) and ReNu multi-purpose solution (Bausch & Lomb, USA). All subjects completed the 16PF inventory and the data were examined for possible associations. Although no overall correlations linking personality with compliance were revealed, some interesting individual correlations were found. The personality trait 'adherence' was found to be associated with the thoroughness of case cleaning (p<0.05) and surfactant cleaning (p<0.05). The personality trait 'extroversion' was found to be associated with the thoroughness of disinfecting (p<0.05) and hand washing (p<0.05). These significant findings may, however, be an artefact of the multiple-testing statistical procedure used. Although it appears that it may be possible to predict compliance with certain aspects of lens wear and care based upon personality assessment, the present finding does not justify the routine application of the full 16PF inventory on contact lens patients. Further work in this area may eventually lead to the formulation of a useful predictive test that can be applied clinically - - such as a simple 10-question test that can predict the likelihood of compliance in patients presenting to the clinic for the first time. A Compliance Enhancement Model Notwithstanding the difficulties discussed above in devising strategies to enhance or predict compliance, it is possible to construct a specific model for compliance enhancement in a contact lens setting based upon a wealth of evidence published in the contact lens field, and drawing upon the extensive literature defining the determinants of compliance in general health care. This model comprises four components: (a) the clinic and the practitioner, (b) the patient, (c) the advice that is given, and (d) the contact lens industry. In essence, the model amounts to a set of general principles and guidelines for enhancing compliance. Each component of the model shall be considered in turn in point form. The Clinic a n d Practitioner
The clinic must have the following qualities in order for
THE TRUTH ABOUT COMPLIANCE
the level of compliance to be optimised:
ISusceptibility Am I susceptible to CL problems?
• staff should be informed and aware of key issues • advice given should be consistent over time and between personnel • appointment times should be individualised (as opposed to 'block booking') • waiting times should be minimal • there should be continuity of care wherever possible • the clinical environment should be friendly.
~yes
no
Severity
[
How severe are the problems?
low
~high
II
IBenefits perceived Can I prevent the problems?
l
noL ÷yes
Barriers perceived Am I able to overcome the barriers?
Important qualities of the practitioner are as follows: • project a devotion to eye care (virtually all eye-care practitioners are devoted to eye care, but sometimes this is kept within) • listen effectively to what the patient has to say • use minimum jargon • emphasise key points, especially after delivery of a long and perhaps complex set of instructions • set specific and realistic goals for patients to aim at • adopt strategies to motivate patients.
,
Compliance
The 'decision tree' which can be used to explore how the health beliefs of a contact lens patient may influence his~her level of compliance.
reduce the likelihood of developing a corneal ulcer"? Negative answer (e.g. "it's all a matter of chance and nothing I do will make any difference"): the patient is likely to be non-compliant Positive answer (e.g. "good hygiene and proper and careful lens care must increase safety"): divert to question 4 Question 4: "Can I afford the paraphernalia and am I disciplined enough to do what I am told"? Negative answer (e.g. "it's all too expensive and too much effort"): the patient is likely to be non-compliant Positive answer (e.g. "I can afford it and I am capable of doing what I am told"): the patient is likely to be compliant.
The Patient
• Question 1: "Am I susceptible to developing a corneal ulcer"? Negative answer (e.g. "the risk is extremely low so it will not happen to me"): the patient is likely to be non-compliant Positive answer (e.g. "this could happen to me"): divert to question 2 • Question 2: "Is a corneal ulcer severe"? Negative answer (e.g. "just a little discomfort for a couple of days"): the patient is likely to be noncompliant Positive answer (e.g. "corneal ulcers are excruciatingly painful and may involve many days of hospitalisation"): divert to question 3 • Question 3: "Is there anything that can be done to
I[
Figure 8.
Strategies for optimising the effectiveness of the aftercare visit include: • sending appointment reminders • advising patients of the importance of regular checkups • providing feedback and reward to patients • repetition of key information • stimulating the patient's interest in vision • providing in-practice information via leaflets, posters, videos, etc.
A valuable approach to determining patient's attitudes is to explore his/her health benefits 19 using a compliance 'decision tree'. Figure 8 is a diagram of such a decision tree. Consider the example of a patient who is contemplating wearing contact lenses and who is generally aware that a potential risk of wearing contact lenses is the development of a corneal ulcer. The answers to the following sequence of questions will indicate whether or not the patient is likely to be compliant with a contact lens system:
~yes
no~
Non-compliance
I
If it is determined that the health beliefs of the patient are likely to lead to non-compliance, steps should be taken to modify the specific beliefs that are erroneous. This can be achieved through a variety of strategies such as talking persuasively, supplying pertinent information or utilising a healthcare contract that emphasises the responsibilities of the patient for achieving safe and comfortable ocular health during lens wear. The Advice
Care systems should be as follows: • • • •
simple and easy to understand tailored for the individual ritualised not too expensive.
Advice given to patients should be verbal and written. Printed material should be readable and well illustrated; clearly illustrated sequential steps with minimum wording will aid understanding and interpretation. Written material should also contain warnings; obviously, a balance must be found whereby 85
NATHANEFRON
patients are alerted to possible dangers but are not frightened away from wearing lenses.
The Contact Lens Industry An important role is played by the contact lens industry in compliance enhancement - - a role that falls into three broad categories: • Pricing policy - - although price reduction did not result in enhanced compliance in the short-term study described earlier, it is self-evident that prohibitive pricing will produce a general disincentive to purchase all of the required products and to use them as required. The contact lens care industry thus has an obligation to contain prices as far as economically possible. • Product support - - clear and unambiguous packaging and simple and clear instructions are thought to be important contributing factors to compliance enhancement; such issues are the sole responsibility of the contact lens industry. Many companies provide attractive 'starter packs' which motivate patients. • Research and development - - contact lens care systems should be designed to be effective, as distinct from the usual practice of designing systems that are merely efficacious. An efficacious system is one which can be demonstrated to work under ideal situations; that is, assuming full patient compliance. An effective system is one which will work in a 'real world' scenario, allowing for a certain level of noncompliance. This review has established that full compliance does not exist. All patients will be at least partially non-compliant in some aspect of their care regimen. If one accepts this argument then it behoves the contact lens industry to develop effective contact lens care systems.
Conclusion Patient compliance with contact lens wear and care is a complex issue; it is difficult to enhance and it is impossible to predict. As a result, we must continue to rely on the outcome of models constructed from the general medical literature and what little has been determined from contact lens research. Practitioners are invited to contemplate all of the issues highlighted in this review when faced with adverse ocular reactions to contact lens wear; although the patient may well be at fault, it is important to avoid taking the easy option of 'blaming the victim'!
86
Acknowledgements I wish to acknowledge the academic input of my colleagues in this research - - Bridget Claydon, Gillian Sheard and Craig Woods, and the fine technical assistance of Michelle Inwood.
Address for Correspondence Professor Nathan Efron, Eurolens Research, Department of Optometry and Vision Sciences, UMIST, PO Box 88, Manchester M60 1QD, UK. REFERENCES J Schein, O.D., Glynn, R.J., Poggio, E.C., Seddon, J.M. and Kenyon, K.R. The relative risk of ulcerative keratitis among users of dailywear and extended-wear soft contact lenses. N. Engl. J. Med., 321, 773-778 (1989). Efron, N., Wohl, A., Toma, N., Jones, L. and l_owe, R. Pseudomonas corneal ulcers associated with daily wear of dispoable hydrogel contact lenses. Int. Contact Lens Clin., 18, 46-52 (1991). 3 Matthews, T.D., Frazer, D.G., Minassian, D.C., Radford, C.F. and Dart, J.K.G. Risks of keratitis and patterns of use with disposable contact lenses. Arch. Ophthalmol., 110, 1559-1562 (1992). 4 Colfins, M.J. and Carney, L.G. Compliance with care and maintenance procedures among contact lens wearers. Clin. Exp. Optom., 69, 174-177 (1986). Katz, H.R, LaBorwit, M.J. and Hirschbeim, M.J. A retrospective study of seasonal influence on ulcerative keratitis. Invest. Ophthalmol. Vis. Sci., 38 [Suppl.], $136 (1997). 6 Sackett, D.L. and Hayes, R.B. Compliance with Therapeutic Regimens, Johns Hopkins University Press, Baltimore (1976). 7 Davidson, S. and Akingbehin, T. Compliance in ophthalmology. Trans. OphthalmoL Soc. UK, 100, 286-290 (1980). 8 Chun, M.W. and Weissman, B.A. Compliance in contact lens care. Am. J. Optom. Physiol. Opt., 64, 274-276 (1987). 9 DiMatteo, M.R. and DiNicola, D.D. Achieving Patient Compliance, Pergamon Press, New York (1982). 10 Claydon, B.E. and Efron, N. Non-compliance in general health care. Ophthal. Physiol. Opt., 14, 257-264 (1994). 11 Claydon, B.E. and Efron, N. Non-compliance in contact lens wear. Ophthal. Physiol. Opt., 14, 356-364 (1994). 12 Vincent, P. Factors influencing patient non-compliance: a theoretical approach. Nursing Res., 20, 509-516 (1971). 13 Claydon, B.E., Efron, N. and Woods, C. A prospective study of noncompliance in contact lens wear. J. Br. Contact Lens Assoc., 19, 133-140 (1996). 14 Claydon, B.E., Efron, N. and Woods, C. A prospective study of the effect of education on non-compliant behaviour in contact lens wear. Ophthal. Physiol. Opt., 17, 137-146 (1997). 15 Claydon, B.E. A Prospective Study of Non-Compliance in Contact Lens Wear, PhD Thesis, UMIST, UK (1995). 1~ Sheard, G., Efron, N. and Claydon, B.E. Does solution cost affect compliance among contact lens wearers? J. Br. Contact Lens Assoc., 18, 59-64 (1995). 17 Radford, C.F., Woodward, E.G. and Stapleton, F. Contact lens hygiene compliance in a university population. J. Br. Contact Lens Assoc., 16, 105-111 (1993). 18 CatteU, R.B., Eber, H.W. and Tatsuoka, M.M. Handbook for the 16PF, Champaign, IL, USA (1988). 19 Sokol, J., Meir, M.G. and Bloom, S. A study of patient compliance in a contact lens wearing population. Contact Lens Assoc. Ophthalmol. J., 16, 209-213 (1990).
© 1997 British Contact Lens Association
Printed in Great Britain
Guest Editorial THE TRUTH ABOUT COMPLIANCE* Nathan
Efront
Abstract-- When confronted with an adverse response to contact lens wear, practitioners are often quick to 'blame the victim'. Although patient compliance may well be lacking, the reasons for this need to be considered carefully, along with all of the other possible contributing factors, if the safety of contact lens wear is to be improved. This Presidential Address briefly reviews what the contact lens Hterature has revealed about patient compliance in the context of what has been known for many years in general eye care and, indeed, general medicine. Essentially, compliance with contact lens systems is poor (40-90% of patients are noncompliant) and difficult to predict in individual patients. Neither a compliance-enhancement strategy (intense education) nor reduction of the cost of goods has any significant effect upon the level of compliance. Assessment of personality is not a reliable compliance predictor. A compliance enhancement model is proposed which encompasses the following four components: (a) the clinic and the practitioner, (b) the patient, (c) the advice that is given, and (d) the contact lens industry. KEYWORDS:
contact lens, patient, compliance, education, cost, personality, practitioner
Introduction ]~Tumerous reports of corneal ulceration in associaI ~l tion with contact lens wear in the professional~-~ and lay literature over the past decade have focused attention on the question of causation. However, the aetiology is not always obvious and the search for the answers is often confounded by vehement defences mounted by those with strong and sometimes conflicting commercial, academic and/or professional interests in the problem. As expected, ophthalmologists treating the ulcers and seeing hospital wards full of contact lens-related corneal ulceration are keen to highlight the problem and those manufacturing and distributing contact lenses and lens care solutions will staunchly defend their products. There is, therefore, a tendency to opt for a simple solution - - to 'blame the victim'! It is of course true that patients can be at fault and unwittingly, carelessly or even recklessly contribute to their own misfortune. An example of recklessness is given in Figure 1; frustrated at the realisation that his aerosol saline can had ceased to spray saline despite the fact that he could still hear saline solution at the bottom of the can - - this patient attempted to saw off the top of the can so that he could use the remaining saline. The fact that patients can effectively contribute to their own misgivings was first recognised by Hippocrates, who wrote in 400 BC "patients are often lying when they say they have regularly taken the prescribed medicine." The issue that Hippocrates was highlighting was that of compliance - - an important * This is a transcript of the BCLA Presidential Address delivered on 3 September 1996 at the Royal Society of Medicine, London. t BScOptom, PhD, DSc, MCOptom, FAAO, FVCO.
Figure 1. Reckless attempt by a patient to obtain residual solution from a can of aerosol saline (because the nozzle had ceased to function) by sawing off the top.
field of medicine that has been the subject of medical research for much of this century. In the contact lens field, studies of compliance commenced only a decade ago, with the first peer-reviewed journal article on this topic being published in 1986 by Collins and Carney# Numerous factors that can contribute to contact lensrelated problems are largely beyond the control of the patient and practitioner, such as the intrinsic safety of contact lenses and lens care solutions, environmental
79
NATHAN EFRON
factors (contact lens-related corneal ulceration is more common in the summer) ~ and personal susceptibility (e.g. atopy or diabetes). One reason for the growing interest in the issue of compliance is that it encompasses many aspects of clinical practice and it is an important defining feature of the practitioner-patient relationship. Another attraction is that compliance can be measured and perhaps manipulated so as to produce a better outcome. Sackett and Hayes6 defined compliance as "the extent to which a patient's behaviour coincides with the clinical prescription". This provides a useful working definition as it essentially defines the two key requirements of the practitioner-patient relationship that are needed in order to avoid adverse events. The aim of this Presidential Address is to (a) present a critical analysis of the issue of compliance, primarily as it relates to contact lens wear, by side-stepping the simple defence of 'blaming the victim' and examining the underlying issues, (b) describe recent research by myself and colleagues that addresses questions relating to the measurement, prediction and modification of non-compliant behaviour, and (c) develop a model for compliance in the contact lens field. That is, I seek to 'reveal the truth' about compliance! Theory of Compliance
Consequences of Non-Compliance It is worth considering the possible consequences of non-compliance because the conclusions from such an analysis provide the rationale for studying compliance. In general, non-compliance will result in the following adverse effects: • • • • •
reduction of treatment efficacy secondary problems incorrect prescribing wasting of practitioner chair time wasting of patient time.
Clearly, healthcare delivery will be enhanced if the above adverse consequences of non-compliance can be minimised or eliminated.
Prediction of Non-Compliance Many of the problems relating to non-compliant patient behaviour could be overcome if it were possible to predict which patients were less likely to be compliant. For example, one might intuitively expect highly educated patients to be more likely to be compliant because they can better understand the instructions given by their practitioner. It might also be expected that patients of a higher socioeconomic status are more likely to be compliant because they can afford to purchase all of the necessary paraphernalia and maintain a more hygienic environment. Unfortunately, most attempts at identifying such predictors have been unsuccessful. For example, Davidson and Akingbehin 7 failed to find an association, in general ophthalmological practice, between non-compliance
80
and the following personal and sociological characteristics: • age •
sex
• • • •
race education occupation socioeconomic status.
Interestingly, Chun and Weissman 8 were able to identify one potentially useful predictor of non-compliance relating to contact lens wear - - patient age. They found that patients under the age of 30 years and over the age of 50 years were more likely to display noncompliant behaviour. Thus, practitioners ought to be alert to compliance-related issues when dealing with contact lens patients in these age ranges.
Extent and Pattern of Non-Compliance It is not possible to simply characterise the behaviour of a patient as compliant or non-compliant, because there will be variations in the pattern and extent of noncompliance. With respect to the pattern of non-compliance a patient may be consistently or inconsistently non-compliant. An example of consistent non-compliance is a patient who never uses a surfactant cleaning solution despite being advised to do so. An example of inconsistent non-compliance is a patient who normally uses a surfactant cleaning solution but does not bother to take it away on holidays (in the interests of 'travelling light') despite being advised to always use such a product. With respect to the extent of non-compliance - - a patient may be totally or partially non-compliant. An example of total non-compliance is a patient who displays serious procedural errors in using all lens care products (e.g. saline, cleaning solution, disinfecting solution, protein removal tablets, etc.). An example of partial non-compliance is a patient who displays serious procedural errors in using some lens care products, while using other lens care products exactly as instructed. Perhaps the most difficult situation to deal with clinically is a patient who is inconsistently and/or partially non-compliant, because the non-compliant behaviour may continue undetected for some time. There is a greater likelihood of detecting consistent and/or total non-compliant behaviours at an aftercare visit. -
-
Duration of the Prescription In the general healthcare field, the extent of non-compliance has been found to be related to the duration of the prescription. For short-term medication (e.g. a 9day course of antibiotics) about 20-30% of patients will be non-compliant. Higher rates of non-compliance are found for long-term regimens: 30-40% of patients are non-compliant with preventative or prophylactic measures (e.g. using sun-protection creams outdoors in patients susceptible to skin cancer) and more than 50%
THE TRUTH ABOUT COMPLIANCE
of patients do not adhere to advice relating to long-term therapy (e.g. ongoing medication for chronic hypertension) .9,10 The prescription of contact lenses and contact lens care systems is akin to a long-term preventative measure; it is therefore not surprising that numerous studies have concluded that about 40-90% of contact lens wearers are non-compliant in at least some aspects of their contact lens care regimes. 11That is, the contact lens literature is in broad agreement with estimates of patient non-compliance documented in the general medical literature. Erroneous Contact Lens Procedures
A complete documentation of the ways in which contact lens patients have been shown to be non-compliant with their wear and care protocols is beyond the scope of this review; however, it is of interest to peruse a summary list (compiled from data reviewed by Claydon and Efron u) of the types of transgressions that can occur: • • • • • • • • •
62% keep solutions too long 40% never clean the lens case 36% irregularly clean lenses 30% do not disinfect lenses daily 30% do not wash hands before handling lenses 27% wear lenses too long 10% never rinse the lens after cleaning 8% never clean lenses 3% clean lenses in tap water.
Compliance with the Incorrect Prescription
The vast majority of practitioners endeavour to dispense the correct and proper prescription; it would be unethical to do otherwise. However, there have been well-documented cases in recent years of practitioners dispensing the incorrect prescription based on misinformation or a misinterpretation. 2,~An example of this is a recommendation to soak disposable lenses overnight in unpreserved saline solution (instead of a multipurpose disinfecting solution) based upon the mistaken belief that frequent lens replacement obviates the need for daily lens disinfection. It is sad to say that a small minority of practitioners knowingly and unethically dispense improper prescriptions, with the usual motivation being greed. An example of such a practice is the dispensing of daily disposable lenses (obtained at very low unit cost) to patients who are advised to dispose of the lenses monthly and are charged a greater fee commensurate with a monthly-replacement modality. Whether inadvertent or deliberate, incorrect prescribing is a reality that must be considered in order to provide a comprehensive analysis of non-compliance. Figure 2 is a flow diagram that reveals five possible outcomes based upon the assumption that an incorrect prescription (or incorrect advice) has been dispensed to the patient. A tick indicates the likelihood of a positive outcome, and a cross indicates the likelihood of a negative outcome.
INCORRECT PRESCRIPTION
I
I
Non-compliance I
I
I
I Deliberate I !
IC°mplianceI ~
IUnintenti°nal I I
I~rrati~,n~l~
X
X
~Iisund~rst°°dI
X
X
Figure 2. Consequences of compliance with the incorrect prescription (a tick indicates the likelihood of a positive outcome and a cross indicates the likelihood of a negative outcome). If the patient is compliant with the incorrect prescription, a negative outcome, such as the development of a corneal ulcer, is more likely. With respect to the example given previously - - a patient complies with the instruction to soak lenses overnight in unpreserved saline. Now consider the case of a patient who is non-compliant with the incorrect prescription. Non-compliance can be deliberate or unintentional. A patient can be deliberately non-compliant in a rational or irrational manner. Continuing with our example - - the decision to use a multi-purpose disinfecting solution (based, say, on previous experience), instead of unpreserved saline as advised, would constitute rational non-compliance. This should result in a positive outcome. A decision to use tap water instead of unpreserved saline as advised (a procedure that perhaps carries an even greater risk of infection), would constitute irrational non-compliance and is likely to lead to a negative outcome. Unintentional non-compliance can be due to forgetfulness or a misunderstanding of the instructions. It is unlikely that unintentional non-compliance will result in correct procedures being re-adopted because of the plethora of random and most likely erroneous procedures that are theoretically available. Compliance with the Correct Prescription
A patient being non-compliant with the correct prescription probably constitutes the classic view taken by practitioners. Consider, then, Figure 3 which is a flow diagram that also reveals five possible outcomes - - but I CORRECT PRESCRIPTION
I
I
Non-compliance I
I
I
I Deliberate ]
[Unintenti°nal I
I
IComplim~cel ~
!
~
V'
~
X
~,Iisund~rstood~
X
X
Figure 3. Consequences of compliance with the correct prescription (a tick indicates the likelihood of a positive outcome and a cross indicates the likelihood of a negative outcome).
81
NATHANEFRON this time based upon the assumption that a correct prescription (or correct advice) has been issued. K the patient is compliant with the correct prescription, a positive outcome is more likely. Now consider the case of a patient who is non-compliant with the correct prescription. An example of a correct prescription is advice to use a multi-purpose contact lens disinfecting solution. As discussed above, non-compliance can be deliberate or unintentional, and deliberate noncompliance can be rational or irrational. Rational noncompliance could be demonstrated, for example, by a decision to use a hydrogen peroxide-based disinfecting solution instead of the multi-purpose as advised. Although most practitioners would prefer that patients do not change their lens care system without prior consultation, such a change would generally be deemed to be safe and would therefore be unlikely to result in a negative outcome. A decision to use tap water (a procedure that carries a greater risk of infection) instead of multi-purpose disinfecting solution as advised, would constitute irrational non-compliance and is likely to lead to a negative outcome. Unintentional non-compliance as a result of forgetfulness or a misunderstanding of the instructions is more likely to result in a negative outcome for reasons given previously.
Compliance Enhancement Research Can Compliance be Enhanced?
Vincent12 conducted a study on a large cohort of glaucoma patients who were specifically told that if they did not comply with the instruction to instil three drops into their eyes daily they could go blind. The outcome of the study was that 50% of patients did not comply often enough, and that there was no improvement in compliance in those who lost sight in one eye. In the light of such results, it is not unreasonable to wonder whether anything can be done to improve compliance among contact lens wearers, especially in view of the fact that the consequences of non-compliance, such as the development of a corneal ulcer, carry a very low absolute risk. A more logical approach might be to assume that there will always be a certain level of noncompliance, and that contact lenses and lens care systems should be designed to have a sufficient level of redundancy, or safety margin, to account for this. Despite the above reservations, the search for viable compliance enhancement strategies needs to continue in view of the known adverse consequences of noncompliance. Below is a description of two experiments that were conducted by myself and colleagues ~3-16 in order to evaluate clinically applicable techniques for enhancing compliance among contact lens wearers. Hypothesis I: Intense initial education enhances compliance This was a 12-month study13,14 conducted on 80
patients who were randomly divided into two groups. Group ! acted as a control. All patients in this group were given the standard 'spiel' (verbal instructions), based on the findings of a survey of the usual patient 82
education delivered by practitioners in the Manchester area. 15 In addition to receiving the standard spiel, patients in Group II were subjected to a 'compliance enhancement strategy', which comprised: • watching a humorous video about compliant and non-compliant behaviour • taking a checklist of procedures to follow • putting up a poster at the point of lens care promoting and reinforcing good practice • signing a healthcare contract emphasising shared responsibility between patient and practitioner. All patients used Medalist contact lenses (38% HEMA daily-wear lenses disposed of monthly) and ReNu multipurpose solution (Bausch & Lomb, USA). All patients returned for an aftercare visit every 3 months. At the 12-month aftercare visit, all patients were examined in random order by a masked observer (who did not know the group to which each patient was assigned) and the level of compliance was assessed by questionnaire and observation of procedures. The patients were not told of the true purpose of the study (they were led to believe that they were evaluating a new brand of contact lens). Thus, this was a single centre, controlled, randomised, double-masked study. Summary results of the percentage of patients who were non-compliant with various aspects of the technique demonstration are presented in Figure 4. By inspection, it seems that the compliance enhancement strategy has been beneficial because the overall level of non-compliance appears to be lower among patients in that group. However, the overall difference was not statistically significant. Hand washing was the only procedure that improved to an extent that was statistically verifiable (p<0.05, ×2 test). Generally, it is concluded that the compliance enhancement strategy failed. It is of interest that the overall level of non-compliance ranged from about 3% to 50%, which is lower than the general estimate of 40% to 90% non-compliance with contact lens systems reported to date. 11 A possible
6O
[] Standard spiel • Intense education
¢J 50 eoEo 30 20
0
Order
Dis,
Case
Rinse
Clean
I
Hand
Figure 4. The percentage of patients who were non-compliant with various aspects of the technique demonstration after 12 months. (Order = order in which procedures were undertaken; Dis. = proper lens disinfection technique," Case = completeness of lens case care; Rinse = proper lens rinsing," Clean = thoroughness of lens cleaning; Hand = thoroughness of hand washing).
T H E TRUTH ABOUT COMPLIANCE
reason for this is that all patients were using a very simple system - - monthly replacement lenses and multi-purpose care solution - - which would be expected in itself to enhance compliance ( it should be noted, however, that this notion has yet to be scientifically validated). Although the use of such a straightforward system may have reduced the sensitivity of this study, the experiment was not invalidated because both the test and control groups used the same system. Summary results relating to the ocular response to lens wear are presented in Figure 5. As expected - because of the absence of a difference in compliance between the two experimental groups - - the intensity of initial education had no bearing on the integrity of the anterior ocular structures.
2.0 t.6 1.8 1.4I
[] Standard spiel • Intense education ]
t- 1 . 2 •~ 1.0 (5
Palp conj
Limb hyp
Bulb hyp
Corn stain
pay' group paid the full retail price of lens care products, whereas the 'nominal pay' group paid a nominal fee for their lens care products (10p per item). All patients used a multi-component lens care system comprising of the following Allergan products: LC-65 cleaner, Oxysept 2-step disinfecting and storage system, saline solution and Ultrazyme protein removal tablets (Allergan, USA),. After 4 months, all unused and part-used bottles and packages were returned and the precise amount of product used (i.e. volume of solution or number of tablets) over the 4-month trial period was determined. A calculation was also made as to the amount of product it was expected that each patient should have used based upon assumptions of correct usage (as indicated by instructions given in the product literature) and a determination of the lens wearing schedule. Figure 6 is a bar graph depicting the ratio of the actual amount of product used to the calculated amount of product used, expressed as a percentage. By inspection, patients seemed to use less Oxysept l&2, saline and Ultrazyme tablets, but more LC-65 cleaner, than expected. These apparent discrepancies were not statistically significant. What is particularly noteworthy in the context of the experimental hypothesis is that there is no significant difference in usage between the 'full pay' and 'nominal pay' groups. That is, reducing cost did not affect compliance as measured by solution usage.
Figure 5. Grading of ocular response (on a scale from 0 [normal] to 4 [severe reaction.]) a/~er 12 months. (Palp conj = palpebral conjunctiva; Limb hyp = limbal hyperaemia; Bulb hyp = bulbar hyperaemia; Corn stain = corneal staining).
Despite the 'negative' or 'no difference' nature of the results of this experiment, important conclusions can be drawn. A clear message to practitioners is that, from a compliance perspective, there is no benefit in overdoing the initial level of education given to contact lens patients. That is, a level of instruction in excess of that currently being offered, as judged from general practices in the Manchester area, is likely to be redundant in terms of enhancing compliance. Putting the issue of compliance aside - - there are other clear benefits of a thorough initial education, such as (a) raising awareness of lens types and lens care products, (b) reinforcing brand loyalty (if this is of interest), and (c) enhancing the patient-practitioner relationship. Although this study failed to demonstrate any compliance-related advantages of providing an enhanced initial instruction, previous research has reinforced the benefits of re-instruction. That is, compliance can be enhanced by constantly reminding patients of correct procedures at aftercare visits. Radford et al. ~7 demonstrated that such an approach improved the rate of compliance in one study group from 44% to 90%. This was a 4-month study 16 conducted on 59 patients who were again randomly divided into two groups. The 'full Hypothesis II: Reducing cost enhances compliance
I ~ ~,,II
-o
~
[~l
E
o~
v
Oxy I
Oxy 2
LC-65
Saline
U'zyme
Figure 6. Ratio of the actual amount of product used to the calculated amount of product used, expressed as a percentage. (Oxy 1 = Oxysept 1; Oxy 2 = Oxysept 2; LC-65 = LC-65 Daily Cleaner," Saline = saline solution; U'zyme = Ultrazyme).
The percentage of patients deemed by demonstration to be non-compliant with respect to a series of key lens care procedures is depicted in Figure 7. Again, there was no statistically significant difference between the 'full pay' and 'nominal pay' groups. The overall level of compliance was very good, which probably relates to the short-term period of follow-up; i.e. a 4-month period probably did not allow sufficient time for bad habits or incorrect practices to manifest. An interesting ramification of this study is that it arms the contact lens solutions industry with a rationale for resisting pressure to reduce the cost of solutions, from a compliance-enhancement perspective, on the basis that reducing solution cost had no beneficial effect upon compliance. There may, however, be other sensible reasons for reducing the cost of care products that relate, for example, to sales and marketing concerns.
83
NATHAN EFRON
60 ~ 50 o
• "When I get what I want, it's usually because I am lucky". • "How many friends I have depends on how nice a person I am". • "My life is chiefly controlled by powerful others". • "Whether or not I get into a car accident depends mostly on the other driver".
[ [] Full pay [ • Nominal pay
c m
~. 4o E o 30 ? c0 20 Z
Case
Order
Dis.
Hands Clean
Rinse
Figure 7. The percentage of patients who were non-compliant with various aspects of the technique demonstration after 4 months. (Case = completeness of lens case care; Order = order in which procedures were undertaken; Dis. = proper lens disinfection technique," Hand = thoroughness of hand washing," Clean = thoroughness of lens cleaning; Rinse = proper lens rinsing).
It is certain that had this experiment been conducted the other way round - - by determining the level of compliance as the cost of care products is increased - - it would have been possible to determine a threshold cost above which patients become dangerously non-compliant. For example, it is unlikely that many patients would be persuaded to pay £100 per bottle of lens cleaner no matter how emphatic the practitioner was as to the importance of lens cleaning. Of course, it is not possible to conduct such a study in the real world. Can Personality be U s e d to Predict NonCompliance? As discussed previously, attempts at predicting which patients are likely to be more compliant, based upon demographics and socioeconomic features, have largely failed. One approach that has not been investigated is the possibility that measurement of certain personality traits can be used to predict a likelihood or otherwise of compliance. Various psychological tests have been devised and discussed in the psychology literature, and some of those of potential relevance to health care have been reviewed by Claydon.1~ One test that has attracted considerable attention is the '16 Personality Factor' (16PF) Inventory.18 In essence, the theory underpinning this test is that personality traits can be divided into the following five categories (each defined in terms of personality extremes): • Surgency - - extroversion v introversion • Agreeableness - - friendly compliance v hostile noncompliance • Will - - conscientious v 'carefree' • Emotional stability-- neuroticism v emotional stability • Intellect - - high v low. The 16PF test is administered by asking each subject to complete an extensive questionnaire comprising a series of statements, each of which must be assessed as to the extent to which the subject agrees or disagrees (on a scale of 0 to 5). Examples of such statements are as follows:
84
Additional analysis can be performed on the data to ascertain secondary personality traits such as 'locus of control'; that is, whether the subject is 'internal' (in control of one's self) or 'external' (controlled by others). The level of compliance with a simple contact lens regime was measured on 48 contact lens wearers using the demonstration and questionnaire techniques described above. 1S All patients used Medalist contact lenses (38% HEMA daily-wear lenses disposed of monthly) and ReNu multi-purpose solution (Bausch & Lomb, USA). All subjects completed the 16PF inventory and the data were examined for possible associations. Although no overall correlations linking personality with compliance were revealed, some interesting individual correlations were found. The personality trait 'adherence' was found to be associated with the thoroughness of case cleaning (p<0.05) and surfactant cleaning (p<0.05). The personality trait 'extroversion' was found to be associated with the thoroughness of disinfecting (p<0.05) and hand washing (p<0.05). These significant findings may, however, be an artefact of the multiple-testing statistical procedure used. Although it appears that it may be possible to predict compliance with certain aspects of lens wear and care based upon personality assessment, the present finding does not justify the routine application of the full 16PF inventory on contact lens patients. Further work in this area may eventually lead to the formulation of a useful predictive test that can be applied clinically - - such as a simple 10-question test that can predict the likelihood of compliance in patients presenting to the clinic for the first time. A Compliance Enhancement Model Notwithstanding the difficulties discussed above in devising strategies to enhance or predict compliance, it is possible to construct a specific model for compliance enhancement in a contact lens setting based upon a wealth of evidence published in the contact lens field, and drawing upon the extensive literature defining the determinants of compliance in general health care. This model comprises four components: (a) the clinic and the practitioner, (b) the patient, (c) the advice that is given, and (d) the contact lens industry. In essence, the model amounts to a set of general principles and guidelines for enhancing compliance. Each component of the model shall be considered in turn in point form. The Clinic a n d Practitioner
The clinic must have the following qualities in order for
THE TRUTH ABOUT COMPLIANCE
the level of compliance to be optimised:
ISusceptibility Am I susceptible to CL problems?
• staff should be informed and aware of key issues • advice given should be consistent over time and between personnel • appointment times should be individualised (as opposed to 'block booking') • waiting times should be minimal • there should be continuity of care wherever possible • the clinical environment should be friendly.
~yes
no
Severity
[
How severe are the problems?
low
~high
II
IBenefits perceived Can I prevent the problems?
l
noL ÷yes
Barriers perceived Am I able to overcome the barriers?
Important qualities of the practitioner are as follows: • project a devotion to eye care (virtually all eye-care practitioners are devoted to eye care, but sometimes this is kept within) • listen effectively to what the patient has to say • use minimum jargon • emphasise key points, especially after delivery of a long and perhaps complex set of instructions • set specific and realistic goals for patients to aim at • adopt strategies to motivate patients.
,
Compliance
The 'decision tree' which can be used to explore how the health beliefs of a contact lens patient may influence his~her level of compliance.
reduce the likelihood of developing a corneal ulcer"? Negative answer (e.g. "it's all a matter of chance and nothing I do will make any difference"): the patient is likely to be non-compliant Positive answer (e.g. "good hygiene and proper and careful lens care must increase safety"): divert to question 4 Question 4: "Can I afford the paraphernalia and am I disciplined enough to do what I am told"? Negative answer (e.g. "it's all too expensive and too much effort"): the patient is likely to be non-compliant Positive answer (e.g. "I can afford it and I am capable of doing what I am told"): the patient is likely to be compliant.
The Patient
• Question 1: "Am I susceptible to developing a corneal ulcer"? Negative answer (e.g. "the risk is extremely low so it will not happen to me"): the patient is likely to be non-compliant Positive answer (e.g. "this could happen to me"): divert to question 2 • Question 2: "Is a corneal ulcer severe"? Negative answer (e.g. "just a little discomfort for a couple of days"): the patient is likely to be noncompliant Positive answer (e.g. "corneal ulcers are excruciatingly painful and may involve many days of hospitalisation"): divert to question 3 • Question 3: "Is there anything that can be done to
I[
Figure 8.
Strategies for optimising the effectiveness of the aftercare visit include: • sending appointment reminders • advising patients of the importance of regular checkups • providing feedback and reward to patients • repetition of key information • stimulating the patient's interest in vision • providing in-practice information via leaflets, posters, videos, etc.
A valuable approach to determining patient's attitudes is to explore his/her health benefits 19 using a compliance 'decision tree'. Figure 8 is a diagram of such a decision tree. Consider the example of a patient who is contemplating wearing contact lenses and who is generally aware that a potential risk of wearing contact lenses is the development of a corneal ulcer. The answers to the following sequence of questions will indicate whether or not the patient is likely to be compliant with a contact lens system:
~yes
no~
Non-compliance
I
If it is determined that the health beliefs of the patient are likely to lead to non-compliance, steps should be taken to modify the specific beliefs that are erroneous. This can be achieved through a variety of strategies such as talking persuasively, supplying pertinent information or utilising a healthcare contract that emphasises the responsibilities of the patient for achieving safe and comfortable ocular health during lens wear. The Advice
Care systems should be as follows: • • • •
simple and easy to understand tailored for the individual ritualised not too expensive.
Advice given to patients should be verbal and written. Printed material should be readable and well illustrated; clearly illustrated sequential steps with minimum wording will aid understanding and interpretation. Written material should also contain warnings; obviously, a balance must be found whereby 85
NATHANEFRON
patients are alerted to possible dangers but are not frightened away from wearing lenses.
The Contact Lens Industry An important role is played by the contact lens industry in compliance enhancement - - a role that falls into three broad categories: • Pricing policy - - although price reduction did not result in enhanced compliance in the short-term study described earlier, it is self-evident that prohibitive pricing will produce a general disincentive to purchase all of the required products and to use them as required. The contact lens care industry thus has an obligation to contain prices as far as economically possible. • Product support - - clear and unambiguous packaging and simple and clear instructions are thought to be important contributing factors to compliance enhancement; such issues are the sole responsibility of the contact lens industry. Many companies provide attractive 'starter packs' which motivate patients. • Research and development - - contact lens care systems should be designed to be effective, as distinct from the usual practice of designing systems that are merely efficacious. An efficacious system is one which can be demonstrated to work under ideal situations; that is, assuming full patient compliance. An effective system is one which will work in a 'real world' scenario, allowing for a certain level of noncompliance. This review has established that full compliance does not exist. All patients will be at least partially non-compliant in some aspect of their care regimen. If one accepts this argument then it behoves the contact lens industry to develop effective contact lens care systems.
Conclusion Patient compliance with contact lens wear and care is a complex issue; it is difficult to enhance and it is impossible to predict. As a result, we must continue to rely on the outcome of models constructed from the general medical literature and what little has been determined from contact lens research. Practitioners are invited to contemplate all of the issues highlighted in this review when faced with adverse ocular reactions to contact lens wear; although the patient may well be at fault, it is important to avoid taking the easy option of 'blaming the victim'!
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Acknowledgements I wish to acknowledge the academic input of my colleagues in this research - - Bridget Claydon, Gillian Sheard and Craig Woods, and the fine technical assistance of Michelle Inwood.
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