aha hypertension journal

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the NHLBI Working GroupManagement of patient compliance in the treatment of hypertension. Report of

ISSN: 1524-4563Copyright 1982 American Heart Association. All rights reserved. Print ISSN: 0194-911X. Online

72514Hypertension is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX

doi: 10.1161/01.HYP.4.3.4151982, 4:415-423 Hypertension

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Management of Patient Compliance in theTreatment of Hypertension

Report of the NHLBI Working Group

R. BRIAN HAYNES, M.D., PH.D., Working Group ChairmanMcMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada

MARGARET E. MATTSON, PH.D., Executive SecretaryNational Heart, Lung, and Blood Institute, Bethesda,Maryland.

ARAM V. CHOBANIAN, M.D., Boston University MedicalSchool, Boston, M assachusetts

JACQUELINE M. DUNBAR, R.N., PH.D. , Stanford Univer-sity School of Medicine, Stanford, California

TILMER O. ENGEBRETSON JR., National Heart, Lungand Blood Institute, Bethesda, M aryland

THOMAS F. GARRITY, PH.D., University of Kentucky Col-lege of Medicine, Lexington, Kentucky

HOWARD LEVENTHAL, PH.D., University of Wisconsin,Departmen t of Psychology, M adison, Wisconsin

ROBERT J. LEVINE, M.D., Yale University School ofMedicine, New H aven, Connecticut

RONA L. LEVY, M.S.W., PH.D., M.P.H., University ofWashington School of Social W ork, Seattle, W ashington

SUM MA RY Low patient cooperation erodes many of the proven benefits of antihypertensive therapy. Overthe last few years, there have been important advances in our understanding of the nature and management ofpatient compliance in hypertension and other chronic illnesses. In this article we review the theoretical founda-tion of compliance behavior; methods of measuring compliance; established and promising approaches tomanaging compliance; ethical considerations in measuring, improving, and researching compliance; the cur-rent state of implementation of compliance techniques in practice settin gs; and the efforts to disseminate infor-mation on compliance through undergraduate and continuing health professional education pro gram s.(Hypertension 4: 415-423 , 1982

K E Y WORDS patient compliance compliance measurement public health education ethics

THE benefits of antihypertensive therapy have

been well documented in both selected popu-lations1 ' 2 and the general com mun ity.8

However, demonstrations of the efficacy of bloodpressure lowering required circumventing patientcompliance as a problem by disqualifying non-compliers from entering the study4 or utilizing extra-ordinary measures to improve com pliance that w ouldbe difficult to apply en block in the usual delivery ofmedical care.8

This review was prepared by an ad hoc committee appointed andsupported by th e National Heart, Lung, and Blood Institute, UnitedStates Department of Health and Human Services. The views ex-pressed herein are those of the authors an d do not necessarily reflectthose of the Institute or the Department.

Address for reprints: M.E. Mattson, Ph .D. , Clinical TrialsBranch, National Heart, Lung, and Blood Institute, Federal Build-ing Room 216,7550 Wisconsin Avenue, Bethesda, Maryland 20205.

Received August 7, 1981; revision accepted October 22, 1981.

Under common conditions of medical practice, theextent to which low patient compliance underminesthe effectiveness of antihypertensive therapy is trulystaggering.6 At each step from detection through long-term follow-up, large numbers of patients fall out ofcare: up to 50% fail to follow throu gh with referral ad-vice;8 '7 over 50% of those who begin treatm ent dropout of care within 1 year;7 9 and only abou t two -thirdsof those who stay under care consum e enough of theirprescribed medication to achieve adequate blood pres-sure reduction.10 ' n It is no won der that studies haverepeatedly shown that only 20% to 30% of individualswho know themselves to be hypertensive are undergood control.1 2'1 S Achieving and maintaining highcompliance with antihypertensive therapy thus present

challenges that must be met if we are to realize thebenefits of modern medical therapy for high bloodpressure.

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416 HYP E RTE NSION VOL 4, No 3, MA Y-JUN E 1982

OUTLINE

Definition of Compliance

Theories of Compliance Behavior

Historical BackgroundEducational ModelHealth Belief ModelEmotional Drive ModelBehavioral Learning ModelSelf-Regulation Model

Measuring Compliance

Monitoring AttendanceClinical JudgmentPatient Self-ReportsPill CountsDrug Level MeasurementBiological Effects A ssessmentPatient Reactivity

Improving Compliance

Screening ProgramsReferral from ScreeningMedication and Follow-Up

New Directions in Improving Compliance

Clinician-Patient RelationshipSocial Support

Ethical Concerns in Applying Compliance Strategies

Utilization of Strategies to Increase Compliance

cides with medical advice.14 Altho ugh this definition ofcompliance is nonjudgmental, for many the term im-plies patient sin and serfdom. Terms that can be usedsynonymously include ad here nce and default-ing , with the former term having perh aps fewernegative connotations.

Theories of Compliance Behavior

Historical Background

The study of compliance behavior holds fascina-tion for those who wish to understand it (withoutnecessarily attempting to modify it) as well as thosewho wish to modify it (without necessarily under-standing it). Theory provides an organizational frame-work through which research can be conducted in anorderly fashion to satisfy both these perspectives.

Theories of compliance behavior have developed inan expected fashion from simplistic to relativelysophisticated. Early theories held that compliance wasrelated to easily tested characteristics of patients ortheir social environments such as age, sex, maritalstatus, education, intelligence, religion, and socio-econom ic status . E mpirical testing of these stru c-tural mo dels failed to reveal consistent relationshipsbetween these variables and compliance, however.16

Studies on situational barrie rs, such as incon-venient clinics and complex regimens, were somewhatmore fruitful but still failed to explain more than afraction of the compliance problems,16 and it followed

that compliance was not much affected by simplymaking treatments easier to follow and treatmentvisits more convenient.19 18

Because it has been only a decade since the first con-vincing demonstration of the efficacy of antihyper-tensive treatment,1-2 it is hardly surprising that in-novative approaches to improving patient acceptanceof this therapy are of recent vintage. Our understand-ing of compliance and of ways to improve low compli-ance has grown considerably during the last fewyears.14 This article is a concise summary of thetheory, research, ethics, and application of compliancemanagement methods in the treatment of hyper-tension as viewed by an interdisciplinary group ofclinicians and researchers convened by the NationalHeart, Lung, and Blood Institute for the purpose ofreviewing current developments in complianceresearch.

D efinition of Compliance

Compliance is the extent to which a person's be-havior (in terms of keeping appointments, takingmedications, and executing life-style changes) coin-

Educational Model

A major theory of compliance behavior holds thatpatients generally lack sufficient knowledge of theirillness and treatment to comply properly and thatthorough instruction will therefore result in bettercompliance. This appears to have merit for short-termtreatments (less than 2 weeks in duration)19 22 but hasvery limited value for chronic disease regimens.11- 23~28

Health Belief odel

The health belief model2 '12 S is perhaps the com-monest mo tivational mo del of compliance. Simplystated, it holds that an individual's cooperation withhealth advice depends upon the extent to which thatperson perceives that he or she is susceptible to the dis-ease, that the disease is serious, that the treatment isefficacious, and that the barriers to compliance arepossible to overcome. A cue to action has also beenbuilt into the model to account for the influence of ex-

ternal factors. Tests of the model show that it doeshave predictive value for at least some preventive andshort-term therapeutic health actions27 -28 but that the

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COMPLIANCE IN HYPERTENSION/AWLS/ Working Group 417

magnitude of its predictive value is modest at best.29 81

Furthermore, communications that influence healthattitudes may have no observable effect on compli-ance,32 34 making the model of less interest from aclinical perspective.

E motional D rive Model

The emotional drive model is related to the healthbelief and educational models in that it attempts toachieve compliance through information about the ill-ness to which is added some form of motivationalappeal. Generally, the motivating part of the messageseeks to arouse fear in the patient about dire conse-quences of failing to comply. A graded effect onbehavior has sometimes been demonstrated, withstronger threat messages effecting greater compli-ance,32- 3 6 but other studies have shown no such grad-ient.33 ' 3


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Pill Counts

Pill counts provide a quantitative estimate ofcompliance over a period of time. This method isrelatively reliable if performed at the patient's homeand with scrupulous attention to bookkeeping,53- S T

but these requirements make it largely impractical forclinical settings. Although it has not been dem-onstrated empirically, it is generally felt that pillcounts are unreliable when they are performed on pillsthat patients bring with them to clinic visits non-compliant patients may bring only some of their un-used pills, or forget to bring their pills with them, orfail to attend the appointment entirely. In general, thepill count gives higher estimates of compliance thanbiological as sa y s - and lower compliance thanpatient self-reports.81 -s3 ' M

Drug Level Measurem entDrug level determinations can be useful, partic-

ularly for drugs that have a sufficiently long half-life tohave minimal fluctuation in plasma concentration dur-ing usual clinical dosing intervals. Fo r exam ple, digox-in s and phenytoin60 '61 plasma levels can provide infor-mation on compliance which can be used to guidecompliance interventions. However, their interpreta-tion is subject to the foibles of individual variation indrug absorpt ion, metabol ism, and excret ion.6 8

Further, drug level assessments are not routinelyavailable for antihypertensive drugs.

Biological Effects Assessment

In contrast to the direct measurement of druglevels, the biologic effects of drugs have not beenfound to correlate well with compliance. For example,thiazide diuretics lower blood pressure and serumpotassium and raise serum uric acid; but none of theseeffects provides as good an indication of compliance assimply asking the patient.83 Nevertheless, in clinicalpractice it would improve efficiency to focus concernabout compliance on only those patients who fail toachieve the therapeutic goal despite prescription of

usually adequate doses of treatment.63

Patient R eactivity

All methods of assessing patient compliance aresusceptible to reac tivity . Th at is, if patients becomeaware of the purpose of the assessment, they may altertheir compliance. Generally, one would expect anychange in compliance to be in a favorable direction,and thus this is a potentially useful phenomenonclinically. For research, it is clearly a hazard if thepurpose of the measurement is solely to document

rather than alter compliance.While no single method of assessing compliance iswholly satisfactory, many of the measures provide

more information than guessing and sequential com-binations of the measures can minimize the amoun t ofeffort required. For example, in routine patient care,compliance need not be considered a problem unlessthe patient fails to respond to usually adequate treat-ment. When the treatmen t response is judged inade-

quate, the patient can be asked about compliance. Ifthe patient reports less than complete com pliance, theclinician can proceed with compliance interventions.If the patient reports full compliance, problems withthe treatment itself can be considered along withapplication of more soph isticated methods of measur-ing compliance.63

Improving Compliance

From the perspective of compliance, optimumcontrol of hypertension in the community will only be

achieved if four aims are met. First, screeningprograms must gain the full cooperation of citizens;second, referral from screening must be successful;third, appointm ents for those in care must be attendedregularly; and finally, medication must be taken asprescr ibed. These four s teps require somewhatdifferent tactics, but research into compliance hasgenerated successful methods of dealing with each ofthem. All of the following methods have been subjectsof controlled clinical trials unless otherwise stated.

Screening Programs

The yield of screening programs can be increased byhome visits, especially if executed outside usual work-ing hours.64 However, most screening programs reachno m ore than 25% of the population,7- M and then onlyfor the duration of the program. Inasmuch as 70% ofthe people visit a physician within a given year,66 itwould seem logical to shift the site of hypertensionscreening to the physician's office. Whether physi-cians will take up this task, however, remains to beseen.

Referral from ScreeningThe success of referral from screening can be aug-

mented by counseling86 and by assisting patients tomake and keep appoin tments .6 7 Al though no tevaluated in controlled trials of compliance strategieswhich would perhaps be unnecessary with the resultsobtained, virtually complete referral success has beenachieved in two studies in which patients werefollowed until at least one appointment had beenkept.17 -88

Medication and Follow-Up

Once the patient is under care for hypertension,additional efforts are usually required to prevent the



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COMPLIANCE IN HYPERTENSION//V7/Ifl/ Working Group 419

patient from dropping out of treatment and to pro-mote full compliance with prescribed therapy. Unfor-tunately, there does not appear to be as yet a single-dose or single-modality cure for noncompliance.Indeed, none of the following methods has improvedcompliance when tested as the only intervention:

special learning packages17

and pamphlets;28

counsel-ing about medication and compliance by a healtheducator;24 home visits;88 increased convenience ofcare at the worksite;17 '70 self-monitoring of bloodpressure;6 -71 tangible rewards;71 group discussions;71

and counseling by nurses.71

In contrast to the lack of effect of unimodal inter-ventions, several controlled trials have shownstatistically and clinically significant increases in com-pliance from combinations of interventions, includingsome that have not worked in isolation. All of theseapproaches are characterized by interactions betweenproviders and patients, leading to the general conclu-

sion that the level of supervision of and attention toongoing care is a key factor.72 Within this framework,there appears to be a variety of effective options for in-teraction. These include feedback of the bloodpressure response to the patient, through bloodpressures taken by either the provider10-78 or the pa-tient;74- rewarding the patient for improved com-pliance and/or lowered blood pressure;28- 7 4 tailor-ing of medications to daily schedules to decreaseforgetting and inconvenience;68 '74 encouraging familysupport;24 engendering self-help through group sup-port and discussion;2 4- negotiating a brief writtencontract with the patient for improvements in healthbehavior;23 and calling back patients who miss ap-pointments.78

A lthou gh a pro vider is present in all of the success-ful interactions, the type of provider does not appearto be important. Physicians,7 ' nurses,8-J8> 68 pharma-cists,10 health educators,24 psyc holo gists, and even in-dividuals with no formal health training74 have playedthe key role in successful interventions. In a similarvein, although a place for provider and patien t to meetis required, the specific site does not appear to be im-portant. Compliance with antihypertensive treatmenthas been increased in community clinics,73 generalmedical clinics,76 hypertension clinics,28-24-7B phar-macies,10 worksites,70-74 and patients ' homes.8

While most interventions were applied directly tothe patient or the patient's family, one study reporteda beneficial effect of tutorials for house staff and at-tending staff in a general medical clinic.76 This studyhas important implications for the education of healthprofessionals.

New D irections in Improving Compliance

The comments in the section above are based on

controlled clinical trials of compliance improvementstrategies which provide us with the most reliable in-formation available on how to improve compliance;

they indicate that several methods are worthwhile.Nevertheless , our understanding of complianceremains incomplete and the ways of improving com-pliance tested to date are both personnel intensive andless than fully effective. Thus, we must continue toseek better understanding of compliance and better

ways to manage it. Two promising avenues of ap-proach to these goals are studies of the clinician-pa-tient relationship and the role of social support incompliance.

Clinician-Patient Relationship

Research into the interactions between cliniciansand patients can be broadly classified into four cate-gories. Studies in the first category d eal with the ped a-gogical techniques employed by practitioners to in-form patients about their prescribed treatment. Thesestudies are both correlational77 80 and experimen-

tal23

- 8 1

in their design and suggest that greater pro-vider explicitness regarding needed patient behaviorsis associated with better patient follow-through.

The second category of studies addresses the extentto which clinicians and patients share the same expec-tations about their interactions and the effect of thison subsequent patient compliance ( mutuality of ex-pectations ). Studies on this topic are difficult to per-form and remain descriptive at present. They indicatetha t when pa tien ts' expec tation s are not fulfilled (fortests they feel should be ordered, and for treatmentsand advice they feel should be rendered), complianceis likely to be low.82 84

The third category includes investigations intopatients' acceptance of responsibility for followingtheir prescribed therapy, a procedure suggested by theself-regulation theories described above. Shulman85

has found that compliance is better among patientswho feel that they are actively involved in their owncare. While no study has yet isolated patient responsi-bility from other elements of the therapeutic process,several studies show that negotiating care with the pa-tient, rather than simply dictating or prescribing it,results in better compliance.11 ' 8e 'M Roter90 also foundthat attendance at appointments improved whenpatients were encouraged to take greater responsi-bility by asking more questions of their physicians.Finally, Nessman et al.7B found that blood pressureswere better controlled and compliance was higheramong patients randomly allocated to monitor theirown blood pressures at home and choose their ownmedications in group sessions, according to a stan-dard step-wise regimen.

The last category concerns the affective tone of thepatient-clinician encounter. The social learning theorydescribed above suggests that liked and powerfulothers would be more influential. This, again, hasproven a difficult matter to study, and no inter-ventional studies have been reported. Studies in whichthe clinician-patient interaction has been observed

directly support the concept that approachability andfriendliness of the clinician to the patient are positivelycorrelated with compliance.80-B 1



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Social Support

The second promising new direction for under-standing and managing patient compliance is that ofsocial support, that is, the help that patients receivefrom their family and friends to carry on with their

treatments. It has been well documented that patientsfrom disrupted or isolated social circumstances areless likely to be good com pliers than those with stablefamilies and/or helpful friends.92 99 Only recently,however, have there been systematic studies ofattempts to engender or direct social support in orderto improve compliance with ant ihypertensive.therapy.24 ' 10 These studies have not shown an inde-pendent effect on compliance of attempting to pro-mote social support, but their results must be regardedas preliminary. Both social learning and self-regula-tion theories point to a number of complex ways thatsocial support could enhance compliance.

E thical Concerns in Applying Compliance Strategies

When attempts are made to improve compliance inmedical practice, rather than in research, the ethicalpractitioner should consider the following guide-lines.101 ' 102 First, the diagnosis must be correct. Sec-ond, the therapy must be of established efficacy.Third, neither the illness nor the proposed treatmentcan be trivial. Fourth , the patient must be an informed

and willing partner in any attempts to alter his compli-ance behavior. Finally, the strategy to be employed toimprove compliance must also be of established merit.Of course, the practitioner must tailor these guide-lines to fit the circumstances of the individual patient:therapies and compliance interventions that benefitmost patients are not suitable for all.

In research, the focus of intent shifts from benefit tothe individual patient to the testing of a hypothesis inorder to develop new knowledge. The compliance con-siderations are somewhat different in this context anddepend on whether the object of the research is testinga new treatment or a new method of improving com-

pliance. If the former, the compliance maneuver usedshould, itself, be of established merit, and we shouldbe able to say that its application will result in moreadequate testing of the new treatment than could beachieved without the compliance maneuver. Arrange-ments should be specified in such studies for detectingharm to patients to permit their prompt removal fromthe study, as an effective compliance maneuver wouldincrease the rate at which harm occurs and poten-tially the severity of any harm.

When the object of research is to test the safetyand/or efficacy of a compliance intervention itself, sayin increasing compliance to a standard antihyper-tensive regimen, there must be good cause to believethat the compliance intervention is worth testing. Thiswould include an adequate theoretical base as well as aprotocol for testing that details an adequate research

design. In both this and the previous research situa-tion, the anticipated harms and benefits must be dis-closed to the prospective research subject who will bethe final arbitor of the favorability of the balance ofharms and benefits, and thus reach a decision c oncern-ing participation in the project.103 105

Monitoring patient compliance also poses ethicalproblems because some of the most powerful methodsof measuring compliance require deception in order tomaintain validity. While this matter merits more dis-cussion than can be provided in this article, the basicethical principles that must be observed are that pa-tients and research subjects must be aware of the fact,if not the details, of measurement and must agree toits execution. Practitioners and investigators shouldavoid circumstances that create the necessity for deceptive debriefing or inflicted insi ght which areharms incurred by informing patients about com-pliance monitoring after the fact.10 8

Ethical issues may seem to be insurmountable bar-riers to the execution of at least some complianceresearch: in particular cases there may be serious ten-sions between the demands of scientific design andobligations to be respectful of the rights and welfare ofhuman subjects. However, the guidelines above arenot absolute but rather enter into a m ore general con-sideration of benefit versus harm in the decision toexecute a research project. Furthermore, it is usuallypossible to negotiate resolutions of such tensions thatall concerned will find satisfactory.

Utilization of Strategies to Increase Compliance

Just as the availability of antihypertensive drugsdoes not ensure that they will be prescribed optimally,the demonstration that various methods of promotingcompliance are effective does not mean that prac-titioners will or do apply them to advantage or thatstudents of the health sciences will be taught them . Weattempted to ascertain the extent of utilization of com-pliance promotion in the public and private healthcare delivery sectors and teaching of compliance

management in schools of medicine, nursing and phar-macy. Sources of information included publishedliterature and direct contact with medical associa-tions, schools, clearing houses, and organizations con-cerned with blood pressure control and education ac-tivities. This informal survey, the details of which arerelated elsewhere,10 7 leads us to a few general con-clusions.

First, there is a vigorous effort being made, partic-ularly throu gh the National High Blood Pressure Edu-cation Program, under the National Heart, Lung, andBlood Institute, to disseminate information aboutmanagement of compliance and long-term follow-upof hypertensive patients, and to organize at the statelevel various intervention programs. Through thisprocess and others, several practical strategies are incommon use including streamlined services, patient



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COMPLIANCE IN HYPERTENSION/A7/fl / Working Group 421

tracking, instruction, and counseling. However, it isnoteworthy that the most frequently used techniques,such as public and patient instruction, are not thoseshown to be the most effective in well-designed con-trolled trials. Second, research in this area continuesto grow rapidly.14 Third, compliance management is

beginning to be taught as a subject in some medicaland other health professional schools. Finally, and un-fortunately, the private practice sector, in which themajority of hypertensives are treated, appears as yetlittle affected by new information about the manage-ment of patient compliance.

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