Compliance → adherence → concordance → self-management →quality of life

Prof. dr. A.A. KapteinMedical PsychologyLeiden University Medical CentreLeidenThe Netherlands

a.a.kaptein@lumc.nl

October 2013

1

Introduction

Illness elicits an enormous set of behaviours in humans.Perceiving symptoms and interpreting them as necessitating theseeking of medical care is one major step. Enduring diagnosticand therapeutic procedures is another. In chronic illness,long-term use of medication is usually required. Managing theillness, and incorporating the illness and its treatment intodaily life, are other major tasks. In short, achieving anacceptable quality of life is a core task in the lives of illpeople all over the world.

In this chapter I will discuss three of the topics mentionedabove: ‘compliance’; self-management; and quality of life[‘compliance’, adherence, and concordance will be discussedtogether in one section]. Some theoretical background regardingthe three main issues will be provided, with empirical studiespresented as illustrations. I will do this from a behaviouralmedicine perspective as this integrates biomedical,behavioural, pharmacological, and societal views, as well asexpertise regarding being ill.

This chapter may serve as a guide for initiating and executingrelatively modest research projects for students of medicine,pharmacology, and psychology. Additional sources are relativelyeasily accessible for this purpose (e.g., French et al., 2010;Ogden, 2012).

Compliance

2

The concept of compliance is of crucial importance in healthcare. Physicians tend to prescribe medication at the end ofvirtually any consultation. Whether health care providers likeit or not, it is at this point that the problems usually begin.For example, patients often do not collect the prescribedmedication at the pharmacy, or take the medication asprescribed (Osterberg et al., 2005).

The traditional definition of compliance is “the extent towhich a person’s behavior (in terms of taking medications,following diets, or executing lifestyle changes) coincides withmedical or health advice” (Haynes, Sackett, & Taylor, 1978). Ina landmark paper, Leventhal and Cameron (1987) describe fourtheoretical views on compliance. I will briefly review thesefour approaches.

In the biomedical approach to compliance the patient isconceptualized as the recipient and performer of medicationregimens that are to be accepted and obeyed. As given in thedefinition of compliance, in the biomedical approach the personuses medication, follows diets, or executes lifestyle changesin accordance with medical or health advice. This theoreticalapproach is associated with a few positive consequences. Theconsistent finding that personality characteristics andsociodemographic background details of patients turn out to beessentially unrelated to compliance has led to much researchabout characteristics from other domains that may predictcompliance behaviour. Disease severity, regimen complexity,duration, and side effects of the treatment are examples ofsuch factors (see Figure 1). The biomedical approach has atleast two problems. It ignores the psychological processesunderlying the patient’s views of his/her illness and medicalmanagement. Secondly, health care providers’ behaviour inencouraging or hampering compliance is not taken into account.

3

Figure 1. Major predictors of poor adherence to medication,according to studies of predictors (Osterberg et al., 2005)

In the social learning approach to compliance, behavioursneeded for compliance to occur are reinforced, and behavioursthat hamper compliance are ignored or even negativelyreinforced (i.e., punished). Rewarding adequate compliance,gradual shaping or patterning of the intended behaviour, andthe training of skills necessary for compliance, are techniquesused in this approach. Problematic in this approach is the lackof long-term efficacy (i.e., the likelihood of relapse). Inaddition, as specific social, cognitive and motivationalprocesses underlying change tend to be unknown, focusedintervention is hardly possible.

The third approach is the communication perspective. Thisapproach views the patient as a novice who seeks the expertadvice and treatment of the clinician. Supportive, warm, andeffective communication skills of the clinician are supposed toencourage the patient to comply with medical advice.Problematic in this approach is that clinicians’ advice turned

4

out to be unclear or even absent, and that action plans arelacking.

The fourth and most recent approach is the self-regulationapproach. Here, the patient is seen as an active problem solverwho creates his/her personal views about the illness and itsmedical and pharmacological management. The patient createsillness perceptions and medication beliefs. These perceptionsand beliefs drive behaviour regarding the management of theillness. Horne is the designer of what he called the extendedself-regulation model (2006; cf., Figure 2) where beliefs about(pharmacological) treatment are incorporated with therepresentations of the illness and its pharmacologicalmanagement. In addition, he proposed a change in terminologywhen talking, thinking, or dealing with ‘compliance’ issues. Itis suggested to replace compliance with adherence, as thisreflects “the extent to which the patient’s behaviour matchesagreed recommendations from the prescriber. It has been adoptedby many as an alternative to compliance, in an attempt toemphasize that the patient is free to decide whether to adhereto the doctor’s recommendations and that failure to do soshould not be a reason to blame the patient. Adherence developsthe definition of compliance by emphasizing the need foragreement.” The most recent term is concordance: “a complexidea relating to the patient/prescriber relationship and thedegree to which the prescription represents a shared decision,in which the beliefs and preferences of the patient have beentaken into consideration” (Horne, 2006). Figure 2 incorporatesthese views.

5

Figure 2. The extended Common Sense Model, conceptualizingadherence (Horne, 2006)

The reader will have noticed that this fourth approach links inwith our second major theme of the chapter, viz., self-management (see box at top of Figure 2).

Self-management

Various models have been developed, and tested, regardingmedical and behavioural medicine management of people withchronic physical illnesses. Two models in particular stand outas having been instrumental in the development of theoreticaland empirical work: (1) the Common Sense Model; and (2) theChronic Care Model.

In the Common Sense Model, the central tenet pertains to themaking sense of physical sensations by people, and theconsequent steps in this process of sense-making (Leventhal,Brissette, & Leventhal, 2003). When a person perceives aphysical sensation, he/she is assumed to be motivated to

6

minimize health-related risks and reduce health threats in afashion consistent with the representations s/he has about anillness. People form these representations based on theirknowledge of the illness, its representation in media (TV,etc.), and encounters with the medical system. It is irrelevantwhether these representations, or illness perceptions, aremedically ‘correct’ (assuming one could even define what‘correct’ means). What is relevant is that these perceptionsguide the response of patients to illnesses, and thereby theirself-management and outcome (see Figure 3). Systematic reviewsand meta-analyses of empirical work employing the Common SenseModel show how illness perceptions are powerful predictors ofoutcome in patients with chronic illnesses (Hagger, & Orbell,2003; Kaptein, Scharloo, Helder, Kleijn, van Korlaar, &Woertman, 2003). At least as

Figure 3. The Common Sense Model (from Hagger, & Orbell,2003).

important is the evidence about the effectiveness ofinterventions in the context of the Common Sense Model. Ifillness perceptions determine outcome, then changing illnessperceptions should lead to changes (i.e., improvements) inself-management and, therefore, in outcome. A number of

7

intervention studies support this prediction. For example,Jansen, Heijmans, Rijken, & Kaptein (2011) describe anintervention programme and its initial encouraging results inpatients with end-stage renal disease and their partners, fromthe perspective of the Common Sense Model. Skinner et al.(2011) report the positive effects of a self-managementintervention in patients with diabetes, where the interventionlead to improvements in illness perceptions, which in turn wereassociated with positive changes in clinical characteristics.

As demonstrated in Figure 4, contextual factors are notexplicitly integrated into the Common Sense Model. However,these issues are part of the second model: the Chronic CareModel (Fisher et al., 2007; www.improvingchroniccare.org ).

Figure 4. The Chronic Care Model (Fisher et al., 2007)

In this model, self-management is embedded into a socialcontext and, in particular, the characteristics of the healthsystem. The elements referred to as ‘community, resources andpolicies’ and ‘health systems, organization of health care’pertain to organizational characteristics of care delivery,where “practitioners have relationships to larger health careorganizations and community resources that can support andenhance high quality chronic illness care” (Wagner 2010, p. S

8

637). Primary care (alternatively referred to as familymedicine or general practice) is conducive in achieving theseconditions. Also, these organizational structures haveimplications for the education of health care professionals(e.g., Bodenheimer, Lorig, Holman, & Grumbach, 2002).

As Wagner and colleagues have noted, self-managementinterventions “generally emphasize the patient’s crucial rolein maintaining health and function and the importance ofsetting goals, establishing action plans, identifying barriers,and solving problems to overcome barriers” (Wagner, Austin,Davis, Hindmarsh, Schaefer, & Bonomi, 2001, p. 74). Theseauthors also importantly point out that “with a few exceptions,the tested interventions do not include long-term support forpatient self-management or efforts to engage the primary careteam” (Wagner et al., 2001, p. 74). Other elements in theChronic Care model outlined in Figure 4, such as deliverysystem designs, decision support, and clinical informationsystems, are aspects which help achieve productive interactionsand improved outcomes.

A systematic literature review of applications of the ChronicCare Model in various chronic physical illnesses leads tomodest optimism (Minkman, Ahaus, & Huijsman, 2007): “someevidence has been found that implementing interventions basedon the Chronic Care Model improves performance (of the healthcare system and its professionals)” (p. 96). In their meta-analysis of interventions to improve care for chronicillnesses, Tsai, Morton, Mangione, & Keeler (2005) review 112studies on asthma, congestive heart failure, depression, anddiabetes in the context of the Chronic Care Model. Theyconclude that “… interventions that contain 1 or more elementsof the Chronic Care Model can improve outcomes and processesfor several chronic illnesses of interest to managed careorganizations” (p. 487). Additional information on theoreticalmodels and their application to the (self-) management ofpatients with chronic physical illnesses is provided by Newmanand colleagues (Newman, Steed, & Mulligan, 2009).

The Common Sense Model and the Chronic Care Model – and relatedmodels (cf. Newman et al., 2009) - point to the increasinglycentral position of the patient in modern medical care for

9

people with chronic illnesses. Figure 5 illustrates thisevolution.

Figure 5. Power to the patient: the increasing involvement ofpatients in medical care (Kaptein et al., 2009)

The concepts of ‘self-management’ and ‘disease management’ atthe top right hand corner of Figure 5 roughly reflect theCommon Sense Model and the Chronic Care Model, respectively.Some 60 years ago, patients were quite often perceived as beingmerely passive recipients of medical care. At best, theirresponses to illness were examined and conceptualized in thecontext of psychopathology, which was thought to contribute tothe somatic disorder. Increasingly, patients have become moreactive partners in their interactions with health careprofessionals. Disease management is the most recent concept inthis evolution. It is defined as “an approach to patient carethat emphasizes coordinated, comprehensive care along thecontinuum of disease and across health care delivery systems –patient counseling and education, coordination, andstandardization are key components” (Peytremann – Brideveaux,Staeger, Brideveaux, Ghali, & Burnand, 2008, p. 434).

Self-management is a key component in the management of chronicillness. We might estimate an ‘average’ patient to have direct

10

face-to-face contact with a health professional in the healthcare system for about one hour per year, which means thatduring the other 8759 hours of the year the patient must managehis or her illness without health care providers. Accordingly,self-management is defined by Barlow and colleagues as: “… theindividual’s ability to manage the symptoms, treatment,physical and psychosocial consequences and life style changesinherent in living with a chronic condition. Efficacious self-management encompasses ability to monitor one’s condition andto effect the cognitive, behavioural and emotional responsesnecessary to maintain a satisfactory quality of life” (Barlow,Wright, Sheasby, Turner, & Hainsworth, 2002, p. 178). Self-management skills are diverse and include such behaviours asgathering information, managing medication, symptoms andpsychological consequences, adjusting lifestyle, mobilizing anddrawing on social support, and communicating effectively(Barlow et al., 2002).

Quality of Life

Although length of survival is an extremely important outcomeof medical care, it is often accompanied by a new concept indiscussions of health outcomes: namely, quality of life (QOL).As a relatively young concept, QOL is defined in many ways. Aconcise definition is provided by Schipper et al.: “thefunctional effect of an illness and its consequent therapy upona patient, as perceived by the patient.” These last five wordsare crucial: it is the perception of the patient of his/her illnessand medical management that determines QOL. Opinions of MDs,nurses, psychologists, and others do not necessarily reflectthe QOL of a patient. Patient Reported Outcomes (PRO) is arecently introduced methodological concept that articulateswith QOL (Calvert et al., 2013). While laboratory data, MRIs,and so on are important in mediating between pathology andmedical care, it is the patient’s verdict on the outcomes thatdefines their QOL. In the Figure 6 below, the traditionalmedical model is depicted, but with one very important extraitem: quality of life.

11

Figure 6. The biomedical model combined with quality of life asoutcome of health care

Typically, QOL can be assessed in three ways: with genericquestionnaires; with disease-specific questionnaires; and withdomain-specific questionnaires.

Generic questionnaires assess QOL irrespective of the illnessunder study. This implies that these questionnaires can be usedin any sample of persons, whether ill or healthy. Usually, QOLquestionnaires assess the functional, psychological, and socialconsequences – as perceived by the patient - of an illness andits treatment. Scores on these questionnaires can be used toassess the effects of medical care in a single patient overtime. They can also be used cross-sectionally to compare QOL inpatients with the same diagnosis. Finally, they allowcomparisons between patients with different diagnosticcategories (e.g., lung cancer vs. breast cancer; or differentcategories of myocardial infarction). The number of generic QOLquestionnaires is relatively limited. The most frequently usedQOL questionnaire is the SF-36, with the SIP (Sickness Impact

12

Profile) and NHP (Nottingham Health Profile) also used quiteoften.

Table 7. Three generic QOL questionnaires in summary: SF-36,SIP, NHP

Functional physical functioning sleep & restphysical abilities role limitations (phys.) bodycare & movement sleep health perceptions homemanagement energy level social functionambulation mobility work

Psychological role limitations (emot.) emotionalbehavior emotional reaction mental healthalertness behavior pain vitalitycommunication painrecreation & pastimes eating

Social social functioning socialinteraction social isolationN items 36136 45www sf-36.orgoutcomes-trust.org qolid.org

SF-36SIP NHP

13

The generic QOL questionnaires are easily accessible toresearchers, and their associated websites give easy access tomanuals, norm data, and instructions for use.

By definition, disease-specific QOL questionnaires can be usedonly for the diagnostic category for which the instrument hasbeen designed. In areas such as oncology, cardiology andendocrinology, an impressive number of disease-specific QOLquestionnaires are available. For example, Perwitasari used theEORTC-BR23 to assess QOL in women with gynecologic cancer(Perwitasari et al., 2011; 2012). Of course, while providingdisease-specific insights, scores cannot be used to compare QOLin women with gynecologic cancer with that of women who have,say, colon carcinoma. Finally, domain-specific QOL questionnaires assess quality oflife in domains that are clinically relevant to more than oneillness. Examples include domains such as pain, nausea,anxiety, or itching. These questionnaires are used when theresearcher is especially interested in assessing a specificcomponent of QOL that might emerge as relevant across a numberof diagnostic categories, but which is less likely to berelevant to a non-clinical population.

Recent research not only assesses QOL as a phenomenon initself, but also frequently uses QOL as an important outcomemeasure in studies of intervention. In addition, QOL is used asan outcome measure in studies that evaluate macro-levelfeatures of healthcare systems, such as whether education bypharmacists or MDs makes an ultimate difference to patientwell-being (refs). It seems safe to conclude that QOL hasbecome an important part of medical care.

Summary

14

A very brief schematic summary of this chapter, which tracesthe development of conceptualizations of how patientperceptions are best considered, is as follows:

compliance → adherence → concordance → self-management → QOL

I have attempted to connect these five concepts by illustratinghow increased patient involvement in medical care seems tobenefit all who are involved.

References

Barlow J, Wright C, Sheasby J, Turner A, & Hainsworth J (2002).Self-management approaches for people with chronic conditions:A review. Patient Education and Counseling, 48, 177 – 187.

Bodenheimer T, Lorig K, Holman H, & Grumbach K (2002). Patientself-management of chronic disease in primary care. JAMA, 288,2469 – 2475.

15

Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, BrundageMD, for the CONSORT PRO Group (2013). Reporting of Patient-Reported Outcomes in randomized trials. The CONSORT PROextension. JAMA, 309, 814 – 822.

Fisher EB, Brownson CA, O’Toole ML, & Anwuri VV (2007). Ongoingfollow-up and support for chronic disease management in theRobert Wood Johnson Foundation diabetes initiative. DiabetesEducator, 33, (Suppl. 6), 201 – 207.

French D, Vedhara K, Kaptein AA, & Weinman J (Eds.) (2010).Health psychology, 2 nd ed. Chichester: Wiley.

Hagger M, & Orbell S. (2003). A meta-analytic review of theCommon-Sense Model of illness representations. Psychology &Health, 18, 141 – 184.

Haynes RB, Sackett DL, Taylor DW. (1978). Practical managementof low compliance with antihypertensive therapy: a guide forthe busy practitioner. Clinical Investigation Medicine, 1, 175– 180.

Jansen DL, Heijmans M, Rijken M, & Kaptein AA. (2011). Thedevelopment of and first experiences with a behavioural self-regulation intervention for end-stage renal disease patientsand their partners. Journal of Health Psychology, 16, 274 –283.

Kaptein AA, Scharloo M, Helder DI, Kleijn WChr, van Korlaar I,& Woertman M. (2003). Representations of chronic illness. In LDCameron, & H Leventhal (Eds.), The self-regulation of healthand illness behaviour (pp. 97 – 118). London: Routledge.

Kaptein AA, Scharloo M, Fischer MJ, Snoei L, Hughes B, WeinmanJ, Kaplan RM, & Rabe KF. (2009). 50 Years of psychologicalresearch on patients with COPD – Road to ruin or highway toheaven? Respiratory Medicine, 103, 3 – 11.

Minkman M, Ahaus K, & Huijsman R. (2007). Performanceimprovement based on integrated quality management models: What

16

evidence do we have? A systematic literature review.International Journal for Quality in Health Care, 19, 90 – 104.

Leventhal H, Brissette I, & Leventhal EA. (2003). The common-sense model of self-regulation of health and illness. In LDCameron, & H Leventhal (Eds.), The self-regulation of healthand illness behaviour (pp. 42 – 65). London: Routledge.

Leventhal H, & Cameron L. (1987). Behavioral theories and theproblem of compliance. Patient Education & Counseling, 10, 117– 138.Minkman M, Ahaus K, & Huijsman R. (2007). Performanceimprovement based on integrated quality management models: Whatevidence do we have? A systematic literature review.International Journal for Quality in Health Care, 19, 90 – 104.

Newman S, Steed L, & Mulligan K. (eds.) (2009). Chronicphysical illness: Self-management and behaviouralinterventions. Maidenhead: McGraw-Hill.

Ogden J. (2012). Health Psychology – a textbook. London:McGrawHill Open University Press.

Osterberg L, & Blaschke T. (2005). Adherence to medication.NEJM, 353, 487 – 497.

Perwitasari DA, Atthobari J, Dwiprahasto I, Hakimi M,Gelderblom H, Putter H, Nortier JWR, Guchelaar HJ, & KapteinAA. (2011). Translation and validation of EORTC QLQ-C30 intoIndonesian version for cancer patients in Indonesia. JapaneseJournal of Clinical Oncology, 41, 519 – 529.

Perwitasari DA, Atthobari J, Mustofa M, Dwiprahasto I, HakimiM, Gelderblom H, Putter H, Nortier JWR, Guchelaar HJ, & KapteinAA. (2012). Impact of chemotherapy-induced nausea and vomitingon quality of life in Indonesian patients with gynecologiccancer. International Journal of Gynecological Cancer, 22, 139– 145.

Peytremann – Brideveaux I, Staeger P, Brideveaux PO, Ghali WA,& Burnand B. (2008). Effectiveness of chronic obstructive

17

pulmonary disease-management programs: Systematic review andmeta-analysis. American Journal of Medicine, 121, 433 – 443.

Skinner TC, Carey ME, Cradock S, Dallosso HM, Daly H, DaviesMJ, Doherty Y, Heller S, Khunti K, Oliver L, on behalf of theDESMOND Collaborative. (2011). Comparison of illnessrepresentations dimensions and illness representation clustersin predicting outcomes in the first year following diagnosis oftype 2 diabetes: Results from the DESMOND trial. Psychology &Health, 26, 321- 335.

Tsai AC, Morton SC, Mangione CM, & Keeler EB. (2005). A meta-analysis of interventions to improve care for chronicillnesses. American Journal of Managed Care, 11, 478 – 488.

Wagner EH. (2010). Academia, chronic care, and the future ofprimary care. Journal of General Internal Medicine, 25 (Suppl4), 636 – 638.

Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, &Bonomi A. (2001). Improving chronic illness care: translatingevidence into action. Health Affairs, 20, 64 – 78.

18